BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    URINE COLLECTION

    MDR report key: 18885295 · Received March 12, 2024

    Report

    Report Number
    1018233-2024-01258
    Event Type
    Malfunction
    Date Received
    March 12, 2024
    Date of Event
    February 21, 2024
    Report Date
    May 9, 2024
    Manufacturer
    C.R. BARD, INC. (COVINGTON) -1018233
    Product Code
    KNX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. 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.

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT WAS INCONCLUSIVE BECAUSE NO SAMPLE WAS AVAILABLE FOR EVALUATION AND FURTHER INVESTIGATION DID NOT RESULT IN ANY ADDITIONAL FINDINGS. ALTHOUGH A ROOT CAUSE COULD NOT BE DEFINITIVELY IDENTIFIED, BASED ON THE RISK DOCUMENTATION REVIEW, A POTENTIAL ROOT CAUSE FOR THIS TYPE OF FAILURE COULD BE ¿INCORRECT ASSEMBLY OPERATION OF TUBE COILING (INCORRECT ASSEMBLY)". HOWEVER, THERE WAS INSUFFICIENT INFORMATION TO CONFIRM THIS POTENTIAL ROOT CAUSE. THE LOT NUMBER IS UNKNOWN; THEREFORE, THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. THE PRODUCT CATALOG NUMBER AND LOT NUMBER FOR THIS DEVICE ARE UNKNOWN. THEREFORE, BD IS UNABLE TO DETERMINE THE ASSOCIATED LABELING TO REVIEW. CORRECTION: H. 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. H3 OTHER TEXT : THE DEVICE WAS NOT RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CUSTOMER WAS REQUESTING REVIEW FOR A RECENT DISCONTINUATION FOR ITEM 802001. THEY STATED THAT THE REPLACEMENT NOW HAD A PORT WHICH WAS CAUSING IRRITATION AND HAD SOME ADDITIONAL CONCERNS THEY WOULD LIKE TO REVIEW AS FAR AS THE PORT BEING SOMEWHAT INCONVENIENT FOR EVERYDAY USE AS IT ADDED WEIGHT TO THE ITEM ITSELF AND HAD ALSO INCREASED IN PRICE. PER FOLLOW UP INFORMATION RECEIVED ON 21FEB2024, IT WAS STATED THAT THE PATIENT HAD USED BARDIA URINARY DRAINAGE BAGS 802001 FOR MANY, MANY YEARS AND THEY WERE THEIR FAVORITE. AS OF LAST YEAR, THEY HAD LEARNED THAT THEY HAVE BEEN DISCONTINUED AND WERE NO LONGER MADE BY BARD OR ANY OTHER MANUFACTURER. THEY HAD RECEIVED SEVERAL DIFFERENT SUBSTITUTIONS FROM UROLOGY SUPPLY COMPANY, LIBERATOR MEDICAL, HOWEVER ALL OF THEM HAD SAMPLE COLLECTION PORTS WHERE THE TUBING CONNECTS TO THE PATIENT. THESE PORTS WERE NOT SOMETHING THEY NEEDED. IT ALSO CAUSED THE CONNECTION TO THE EXTERNAL CATHETER TO BE HEAVIER AND THEREFORE SOMETIMES KINKED OR DID NOT REST SMOOTHLY IN PLACE ONCE ATTACHED TO THE EXTERNAL CATHETER. THEY HAD SEEN ON OTHER SPINAL CORD INJURY AND UROLOGICAL FORUMS THAT MANY OTHER PATIENTS MISSED THE DISCONTINUED DRAINAGE BAG WITHOUT THIS COLLECTION PORT (#802001).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CUSTOMER WAS REQUESTING REVIEW FOR A RECENT DISCONTINUATION FOR ITEM (B)(4). THEY STATED THAT THE REPLACEMENT NOW HAD A PORT WHICH WAS CAUSING IRRITATION AND HAD SOME ADDITIONAL CONCERNS THEY WOULD LIKE TO REVIEW AS FAR AS THE PORT BEING SOMEWHAT INCONVENIENT FOR EVERYDAY USE AS IT ADDED WEIGHT TO THE ITEM ITSELF AND HAD ALSO INCREASED IN PRICE. PER FOLLOW UP INFORMATION RECEIVED ON 21FEB2024, IT WAS STATED THAT THE PATIENT HAD USED BARDIA URINARY DRAINAGE BAGS (B)(4) FOR MANY, MANY YEARS AND THEY WERE THEIR FAVORITE. AS OF LAST YEAR, THEY HAD LEARNED THAT THEY HAVE BEEN DISCONTINUED AND WERE NO LONGER MADE BY BARD OR ANY OTHER MANUFACTURER. THEY HAD RECEIVED SEVERAL DIFFERENT SUBSTITUTIONS FROM UROLOGY SUPPLY COMPANY, LIBERATOR MEDICAL, HOWEVER ALL OF THEM HAD SAMPLE COLLECTION PORTS WHERE THE TUBING CONNECTS TO THE PATIENT. THESE PORTS WERE NOT SOMETHING THEY NEEDED. IT ALSO CAUSED THE CONNECTION TO THE EXTERNAL CATHETER TO BE HEAVIER AND THEREFORE SOMETIMES KINKED OR DID NOT REST SMOOTHLY IN PLACE ONCE ATTACHED TO THE EXTERNAL CATHETER. THEY HAD SEEN ON OTHER SPINAL CORD INJURY AND UROLOGICAL FORUMS THAT MANY OTHER PATIENTS MISSED THE DISCONTINUED DRAINAGE BAG WITHOUT THIS COLLECTION PORT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1029277 URINE COLLECTION URINE COLLECTION KNX C.R. BARD, INC. (COVINGTON) -1018233 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other