BUSSE HOSPITAL DISPOSABLES

Description of Event or Problem

(B)(6) HOSPITAL DISPOSABLES IS SUBMITTING THIS MEDWATCH REPORT AS A RESPONSE TO A CUSTOMER SUBMITTED MEDWATCH UNDER UFI/IMPORTER REPORT#: (B)(4), WHICH WAS RECEIVED AT OUR FACILITY ON (B)(6) 2022. THE INITIAL REPORTER HAS BEEN CONTACTED A TOTAL OF SEVEN TIMES TO DATE. IN THE MEDWATCH IT IS REPORTED THAT THE CURETTE/HANDLE "DOES NOT ROTATE PROPERLY" THE REPORTER ( (B)(6), RISK MANAGER AT (B)(6) HEALTHCARE) WAS IMMEDIATELY CONTACTED BY EMAIL (AS NOTED IN THE MEDWATCH REPORT) ON THAT SAME DATE. AN ACKNOWLEDGEMENT LETTER WAS SENT WITH THE COMMUNICATION, AS A COMPLAINT WAS IMMEDIATELY ISSUED/OPENED IN ORDER TO INVESTIGATE THE FEEDBACK GIVEN IN THE MEDWATCH REPORT. AS NO CATALOG, OR LOT NUMBERS WERE INCLUDED IN THE REPORT, IT WAS ALSO REQUESTED IN THE EMAIL TO PROVIDE , ALONG WITH OTHER INFORMATION USING (B)(6) FORM "DEVICE COMPLAINT FORM." ON (B)(6) 2022, AS THERE HAD BEEN NO RESPONSE MRS. (B)(6) WAS CONTACTED IN THE SAME EMAIL THREAD (SHE WAS NOTED AS THE CONTACT PERSON IN , HER EMAIL INFORMATION WAS OBTAINED ONLINE). ON THIS SAME DAY, MRS. (B)(6) RESPONDED TO OUR EMAIL NOTING THAT SHE HAS NOT BEEN ABLE TO GATHER THE INFORMATION REQUESTED FROM (B)(6)HEALTHCARE'S MATERIALS MANAGEMENT DEPARTMENT BUT WAS HOPING TO RECEIVE THE INFORMATION THAT AFTERNOON. ON (B)(6) 2022 (B)(6) REQUESTED FURTHER INFORMATION ALONG WITH THE DCF (FORM) PREVIOUSLY REQUESTED, AS WE HAD DISCUSSED THE DESCRIBED IN THE REPORT; CURETTES BY DESIGN DO NOT HAVE THE ABILITY TO ROTATE ALONE - WE WERE TRYING TO CLARIFY WHETHER THE REPORT WAS FOR THE CURETTES OR A HANDLE. WE REQUESTED THE FOLLOWING: THE HANDLE AND TUBING ADVENTIST WAS USING WITH THE CURETTE WHETHER SAMPLES WERE AVAILABLE AND IF THEY WOULD BE SUBMITTED ON (B)(6) AS THERE HAD BEEN NO RESPONSE FROM MR. (B)(6), SHE WAS CONTACTED BY PHONE ( (B)(6)) AT 10:30AM. SHE REPORTED AGAIN THAT SHE IS STILL PENDING ON THE INFORMATION FROM HER MATERIALS DEPARTMENT BUT WOULD WORK ON GETTING IT. IT WAS NOTED DURING THIS CALL THE URGENCY TO OBTAIN THIS INFORMATION, AS (B)(6) MUST ALSO INVESTIGATE AND SUBMIT A MEDWATCH IN RESPONSE TO (B)(6) HEALTHCARE'S SUBMITTED. ON (B)(6), IN THE AFTERNOON, AS NO RESPONSE HAD BEEN RECEIVED A FOLLOW-UP EMAIL WAS SENT TO (B)(6) HEALTHCARE/MRS. (B)(6), NOTING AGAIN THE URGENCY TO OBTAIN THE INFORMATION REQUESTED. SHE REPLIED THAT SHE HAD YET TO RECEIVE THE INFORMATION FROM HER MATERIALS DEPARTMENT. BUT CLARIFIED THE REPORT WAS NOT ON THE CURETTES BUT ON THE HANDLE. (B)(6) THANK HER FOR PROVIDING THE CLARIFICATION AND RESENT THE FORM THAT HAD BEEN REQUESTED TO SUBMIT CATALOG AND LOT INFORMATION. ON (B)(6), ANOTHER EMAIL WAS SENT TO MR. (B)(6) REQUESTING ANY SORT OF INFORMATION AVAILABLE (CATALOG OR LOT AT LEAST). SHE REPLIED THAT THERE IS STILL NO INFORMATION BUT NOW HAS THE STERILE PROCESSING DEPARTMENT ASSISTING TO OBTAINED THE INFORMATION. TODAY, (B)(6), IT WAS REPORTED TO (B)(6) MANAGEMENT THAT (B)(6) HEALTHCARE HAS YET TO PROVIDE INFORMATION AFTER MULTIPLE FOLLOW-UPS. MANAGEMENT INSTRUCTED TO SUBMIT (B)(6) MEDWATCH WITH THE INFORMATION THUS FAR AND REQUEST FROM MRS. (B)(6) HER SUPERIOR'S CONTACT INFORMATION. THUS FAR, IT CAN BE CONCLUDED, AS THE HANDLES (B)(6) MANUFACTURE DO NOT HAVE THE ABILITY TO ROTATE, THAT THE PRODUCT, IF (B)(6) WORKS ACCORDING TO SPECIFICATION. NONETHELESS, AS THERE IS NO OTHER INFORMATION OR SAMPLES, NO FURTHER INVESTIGATION CAN BE MADE. WE WILL CONTINUE TO ATTEMPT TO GET INFORMATION FROM (B)(6) HEALTHCARE ONCE MR. (B)(6) PROVIDES HER SUPERIOR'S INFORMATION.

Additional Manufacturer Narrative

AS DESCRIBED IN A PREVIOUS SECTION, WE HAVE TRIED TO OBTAIN INFORMATION FROM (B)(6)HEALTHCARE MULTIPLE TIMES THROUGH EMAIL AND PHONE AND HAVE NOT BEEN ABLE TO OBTAIN IT. HOWEVER, AS WE CANNOT CONFIRM THIS IS A BUSSE PRODUCT, OR VALIDATE THE REPORTED THROUGH A LOT OR CATALOG, (B)(6) HAS REQUESTED TO SPEAK TO A SUPERIOR OF MRS. (B)(6) AT (B)(6) MEDICAL. IF NO INFORMATION CAN BE RETRIEVED, THEN A FOLLOW UP MEDWATCH WILL BE SUBMITTED NOTING THIS OR IF THE INFORMATION IS PROVIDED, WE WILL UPDATE WITH INVESTIGATIONAL FINDING. IN GENERAL, WE CAN INFER THAT THE REPORT IS NOT VALID, AS BUSSE MADE HANDLES ARE NOT MADE WITH THE SPECIFICATION TO ROTATE.

Additional Manufacturer Narrative

AS DESCRIBED IN SECTION B.5 OF THIS SUBMISSION, THE INITIAL REPORTER DID NOT PROVIDE ANY VIABLE INFORMATION TO CONDUCT AN INVESTIGATION AND EVEN AFTER REQUESTED INFORMATION FROM A SUPERVISOR, THERE WAS NO RESPONSE. BUSSE CANNOT CONDUCT AN INSPECTIONS, AND WITHOUT SAMPLE WE ARE UNABLE TO CONFIRM THE REPORT WAS MADE FOR A BUSSE MANUFACTURED PRODUCT. OUR POST MARKET SURVEILLANCE DATA DOES NOT INDICATE ANY ISSUES WITH OUR HANDLES TO REQUIRE ANY SORT OF ACTION NOR DOES IT CONFIRM THE REPORTED UNDER THE MEDWATCH SUBMITTED BY ADVENTIST HEALTHCARE. BOTH, MRS. (B)(6) AND MRS. (B)(6), HAVE BEEN MADE AWARE OF THIS AND HAVE BEEN NOTIFIED THAT FOR THE ABOVE REASONS AN INVESTIGATION CANNOT BE CONDUCTED. THE COMPLAINT OPENED WILL BE CLOSED, NONETHELESS, MRS. (B)(6) IS ADVISED TO SUBMIT THE INFORMATION IF IT BECOMES AVAILABLE AT ANY POINT.

Description of Event or Problem

THIS IS FOLLOW-UP #1 FOR MEDWATCH, MFR REPORT #: 2433012-2022-00001 SUBMITTED TO THE FDA ON (B)(6) 2022. PLEASE REFER TO THIS REPORT FOR INITIAL DETAILS SUBMITTED. UNDER (B)(6) HOSPITAL DISPOSABLES' MANAGEMENT INSTRUCTIONS, MRS. (B)(6) AT ADVENTIST HEALTHCARE WAS REQUESTED TO PROVIDE HER SUPERVISOR'S INFORMATION (TELEPHONE NUMBER AND EMAIL) THROUGH EMAIL ON (B)(6) 2022. ON THIS SAME DATE, MRS. (B)(6) REPLIED WITH HER SUPERVISOR'S EMAIL AND NAME: (B)(6). EMAIL: (B)(6). ON (B)(6) 2022 BUSSE CONTACTED THIS INDIVIDUAL PROVIDING A RECAP OF ALL THE EVENTS THAT HAD TAKEN PLACE AND REQUESTED HELP OBTAINING THE INFORMATION THAT HAS BEEN REQUESTED FROM MRS. (B)(6). THE SUPERVISOR WAS ALSO MADE AWARE THAT THE INITIAL MEDWATCH HAD BEEN SUBMITTED DETAILING THESE EVENTS AND ATTACHED WITH COMUNICATIONS WITH MRS. (B)(6). AS OF TODAY, THERE HAS BEEN NO RESPONSE FROM MRS. (B)(6). THEREFORE, BUSSE HOSPITAL DISPOSABLES FIND IT NONVIABLE TO CONDUCT AN INVESTIGATION ON THE MEDWATCH SUBMITTED BY MRS. (B)(6) AT ADVENTIST HEALTHCARE SHADY GROVE (UNDER UF/IMPORTER REPORT#2100570000-2022-8001); WITHOUT A CATALOG, LOT AND/OR SAMPLE IT IS DIFFICULT TO DO SO OR CONFIRM THE REPORT IS INDEED FOR A BUSSE MANUFACTURED PRODUCT. FURTHERMORE, BUSSE'S REVIEW OF OUR EXISTING DATA AND POST MARKET SURVEILLANCE ACTIVITIES, HAS NOT IDENTIFIED ANY TRENDS OR SIMILAR REPORTS FOR OUR CURETTES.