UNKNOWN MALE EXTERNAL CATHETER

Additional Manufacturer Narrative

THE REPORTED EVENT WAS INCONCLUSIVE BECAUSE THIS INVESTIGATION DID NOT RESULT IN ANY ADDITIONAL FINDINGS AND NO SAMPLE WAS AVAILABLE FOR EVALUATION. THE PRODUCT CATALOG NUMBER AND THE LOT NUMBER FOR THIS DEVICE ARE UNKNOWN. THEREFORE, BD IS UNABLE TO DETERMINE THE ASSOCIATED LABELING TO REVIEW. A DHR COULD NOT BE PERFORMED SINCE NO LOT NUMBER WAS PROVIDED. NO ADDITIONAL ACTIONS CAN BE TAKEN AT THIS TIME. THE REPORTED PRODUCT NUMBER IS UNKNOWN. THE UDI NUMBER FOR THIS PRODUCT IS NOT AVAILABLE. H11: SECTIONS A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD.

Description of Event or Problem

IT WAS REPORTED THAT THE CRITICAL CARE NURSE STATED THAT THE ONLINE SURVEY A NURSE STATED "NO" IN THE QUESTION "CONSIDERING THE 24 HOUR PERIOD IN WHICH YOU LAST USED A BARD BD MALE EXTERNAL CONDOM CATHETER ON YOUR PATIENT, PLEASE ANSWER THE FOLLOWING QUESTIONS. WAS THE DEVICE SUCCESSFULLY USED FOR THE DESIRED DURATION OF USE?" WHILE USING THE PRODUCT "WIDEBAND SELF ADHERING MALE EXTERNAL CONDOM CATHETER", AND IN QUESTION "CONSIDERING THE 24 HOUR PERIOD IN WHICH YOU LAST USED A BARD OR BD MALE EXTERNAL CONDOM CATHETER ON YOUR PATIENT. WHY WAS THE DEVICE NOT SUCCESSFULLY USED FOR THE DESIRED DURATION OF USE?" ANSWERED "HARD TO INSTALL". ADDITIONALLY, THE NURSE STATED "YES" FOR THE QUESTIONS: "DID YOUR PATIENT EXPERIENCE PENILE SKIN IRRITATION AS A RESULT OF DEVICE USAGE?" "DID YOUR PATIENT EXPERIENCE PENILE BLEEDING AS A RESULT OF DEVICE USAGE?" "DID YOUR PATIENT EXPERIENCE PENILE URETHRAL INJURY AS A RESULT OF DEVICE USAGE?" AND "DID YOUR PATIENT EXPERIENCE A UTI AS A RESULT OF DEVICE USAGE?" BESIDES, IN QUESTION "CONSIDERING THE 24 HOUR PERIOD IN WHICH YOU LAST USED A BARD OR BD MALE EXTERNAL CONDOM CATHETER ON YOUR PATIENT, DID YOUR PATIENT EXPERIENCE ANY OTHER ADVERSE EVENTS?" THE NURSE STATED "YES" AND FOR THE QUESTION "PLEASE DESCRIBE THE OTHER ADVERSE EVENT(S) EXPERIENCED BY YOUR LAST PATIENT WHEN CONSIDERING THE 24 HOUR PERIOD IN WHICH YOU LAST USED THE BARD OR BD MALE EXTERNAL CONDOM CATHETER." THE ANSWER WAS "ISSUE WITH CLEANLINESS". FURTHERMORE FOR THE QUESTION "CONSIDERING THE 24HOUR PERIOD IN WHICH YOU LAST USED A BARD OR BD MALE EXTERNAL CONDOM CATHETER ON YOUR PATIENT, DID YOUR PATIENT REQUIRE ANY MEDICAL OR SURGICAL INTERVENTION AS A RESULT OF DEVICE USAGE?" THE NURSE STATED "YES" AND IN QUESTION "PLEASE DESCRIBE THE MEDICAL OR SURGICAL INTERVENTION THAT RESULTED WHEN CONSIDERING THE 24HOUR PERIOD IN WHICH YOU LAST USED THE BARD OR BD MALE EXTERNAL CONDOM CATHETER." ANSWERED "STABLE 50 YEAR OLD MALE PATIENT AND NO COMPLICATIONS".

Additional Manufacturer Narrative

THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. THE REPORTED PRODUCT NUMBER IS UNKNOWN. THE UDI NUMBER FOR THIS PRODUCT IS NOT AVAILABLE. H11: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD.

Description of Event or Problem

IT WAS REPORTED THAT THE CRITICAL CARE NURSE STATED THAT THE ONLINE SURVEY A NURSE STATED "NO" IN THE QUESTION "CONSIDERING THE 24-HOUR PERIOD IN WHICH YOU LAST USED A BARD/BD MALE EXTERNAL CONDOM CATHETER ON YOUR PATIENT, PLEASE ANSWER THE FOLLOWING QUESTIONS. WAS THE DEVICE SUCCESSFULLY USED FOR THE DESIRED DURATION OF USE?" WHILE USING THE PRODUCT "WIDEBAND SELF-ADHERING MALE EXTERNAL CONDOM CATHETER", AND IN QUESTION "CONSIDERING THE 24-HOUR PERIOD IN WHICH YOU LAST USED A BARD/BD MALE EXTERNAL CONDOM CATHETER ON YOUR PATIENT. WHY WAS THE DEVICE NOT SUCCESSFULLY USED FOR THE DESIRED DURATION OF USE?" ANSWERED "HARD TO INSTALL". ADDITIONALLY, THE NURSE STATED "YES" FOR THE QUESTIONS: "DID YOUR PATIENT EXPERIENCE PENILE SKIN IRRITATION AS A RESULT OF DEVICE USAGE?", "DID YOUR PATIENT EXPERIENCE PENILE BLEEDING AS A RESULT OF DEVICE USAGE?", "DID YOUR PATIENT EXPERIENCE PENILE URETHRAL INJURY AS A RESULT OF DEVICE USAGE?" AND "DID YOUR PATIENT EXPERIENCE A UTI AS A RESULT OF DEVICE USAGE?". BESIDES, IN QUESTION "CONSIDERING THE 24-HOUR PERIOD IN WHICH YOU LAST USED A BARD/BD MALE EXTERNAL CONDOM CATHETER ON YOUR PATIENT, DID YOUR PATIENT EXPERIENCE ANY OTHER ADVERSE EVENTS?" THE NURSE STATED "YES" AND FOR THE QUESTION "PLEASE DESCRIBE THE OTHER ADVERSE EVENT(S) EXPERIENCED BY YOUR LAST PATIENT WHEN CONSIDERING THE 24-HOUR PERIOD IN WHICH YOU LAST USED THE BARD/BD MALE EXTERNAL CONDOM CATHETER." THE ANSWER WAS "ISSUE WITH CLEANLINESS". FURTHERMORE, FOR THE QUESTION "CONSIDERING THE 24-HOUR PERIOD IN WHICH YOU LAST USED A BARD/BD MALE EXTERNAL CONDOM CATHETER ON YOUR PATIENT, DID YOUR PATIENT REQUIRE ANY MEDICAL OR SURGICAL INTERVENTION AS A RESULT OF DEVICE USAGE?" THE NURSE STATED "YES" AND IN QUESTION "PLEASE DESCRIBE THE MEDICAL OR SURGICAL INTERVENTION THAT RESULTED WHEN CONSIDERING THE 24-HOUR PERIOD IN WHICH YOU LAST USED THE BARD/BD MALE EXTERNAL CONDOM CATHETER." ANSWERED "STABLE 50-YEAR-OLD MALE PATIENT AND NO COMPLICATIONS".