PERIFIX®

Description of Event or Problem

AS REPORTED BY THE USER FACILITY: EVENT 2 DETAILED INQUIRY DESCRIPTION 0061926202 - ELMWOOD. 0061923788 - BAPTIST. HEY (B)(6), ABOVE ARE THE TWO LOT NUMBERS FOR THE CATHETER TRAYS WE DISCUSSED YESTERDAY. I AM STILL TRYING TO GET THE LOT NUMBER FROM MAIN CAMPUS. JUST AS A REFRESHER - WE HAVE HAD 4 INSTANCES IN THE PAST TWO WEEKS OF EPIDURAL CATHETERS GETTING "STUCK" DURING THE REMOVAL PROCESS. ON THREE OF THOSE OCCASIONS, THE PLASTIC COVERING EVENTUALLY SHEARED, AND VARYING AMOUNTS WERE POSSIBLY LEFT IN THE PATIENT. I CAN SPEAK TO THE REMOVAL I WAS A PART OF, AND IT SEEMED LIKE THE SPRINGWOUND COIL WAS FULLY REMOVED, BUT THE LAST 2-3 CM WAS SHEARED OFF AND NOT PRESENT. ON THE FOURTH OCCASION, THE CATHETER WAS ABLE TO BE REMOVED BUT THE BLUE TIP WAS NOT PRESENT, AND IT WAS UNCLEAR AS TO WHETHER THE CATHETER WAS SHEARED OR IF THE BLUE COLOR HAD SIMPLY WORN OFF FROM THE TIP. AS I CONTINUE TO DISCUSS THIS ISSUE WITH ADDITIONAL STAFF, ALMOST ALL SEEM TO AGREE THAT THEY FEEL THERE HAS BEEN A NOTICEABLE DIFFERENCE IN CATHETER QUALITY OVER THE PAST FEW MONTHS, AT LEAST.

Additional Manufacturer Narrative

THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INTERNAL REPORT NUMBER (B)(4). THE INVESTIGATION IS ONGOING AT THIS TIME. A FOLLOW-UP WILL BE SUBMITTED WHEN THE INVESTIGATION RESULTS BECOME AVAILABLE.

Description of Event or Problem

PER ADDITIONAL INFORMATION RECEIVED BY THE CUSTOMER: EVENT 3: CATHETER SHEARED, 2-3 CM REMAINS IN THE PT, COIL FULLY REMOVED. DATE: UNK. LOCATION (HOSPITAL SITE): OCHSNER - MAIN CAMPUS (B)(6). PRODUCT CODE: 332097. LOT NUMBER: UNKNOWN. PT GENDER/AGE IF AVAILABLE: MALE. PT OUTCOME: (REQUIRED REMOVAL SURGERY, NO INTERVENTION?)? OCCURRED ON REMOVAL, NO ADVERSE OUTCOMES, NO ADDITIONAL INTERVENTIONS.

Additional Manufacturer Narrative

THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INTERNAL REPORT NUMBER (B)(4). ADDITIONAL INFORMATION WAS RECEIVED REGARDING EVENTS INITIALLY REPORTED. INITIAL REPORT WAS NOTED TO BE EVENT 2 FOR B. BRAUN MEDICAL INTERNAL REPORT NUMBER (B)(4). THIS HAS NOW BEEN UPDATED TO B. BRAUN MEDICAL INTERNAL REPORT NUMBER (B)(4).

Additional Manufacturer Narrative

THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INTERNAL REPORT NUMBER (B)(4). NO SAMPLE WAS PROVIDED FOR EVALUATION. BASED ON THE DATA FROM THE INVESTIGATION WE ARE UNABLE TO DETERMINE THE ROOT CAUSE OF THE REPORTED INCIDENT. THE REPORTED DEFECT WAS UNABLE TO BE CONFIRMED. THE ACTUAL DEFECTIVE DEVICE IS A VALUABLE TOOL IN INVESTIGATING THE CAUSE OF THIS INCIDENT. WE WILL MAINTAIN THIS REPORT FOR FURTHER REFERENCES AND CONTINUE TO MONITOR OTHER REPORTS FOR SIMILAR OCCURRENCES. IF ANY ADDITIONAL PERTINENT INFORMATION BECOMES AVAILABLE, A FOLLOW UP WILL BE SUBMITTED.