BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    URINE COLLECTION DRAIN BAG

    MDR report key: 14496527 · Received May 25, 2022

    Report

    Report Number
    1018233-2022-04092
    Event Type
    Malfunction
    Date Received
    May 25, 2022
    Date of Event
    May 5, 2022
    Report Date
    August 18, 2022
    Manufacturer
    C.R. BARD, INC. (COVINGTON) -1018233
    Product Code
    KNX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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. THE DEVICE WAS NOT RETURNED.

    Additional Manufacturer Narrative · 0

    UPON FURTHER REVIEW, BD HAS DETERMINED THAT THIS MDR WAS REPORTED IN ERROR AS IT WAS FOUND TO BE A CASCADING FAILURE OF AN EVENT PREVIOUSLY REPORTED. H11: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF 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 BARD. H3 OTHER TEXT : THE DEVICE WAS NOT RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE LEG BAG VELCRO STRAPS WERE UNCOMFORTABLE ((B)(4)), AND THE LEG BAGS WOULD STICK TO THE SKIN WHICH CAUSED PAIN WHEN STANDING UP AND DOWN ((B)(4)). ALSO STATED THAT THERE WAS AN IRRITATION IN THE URINARY TRACT FROM THIS ISSUE AND THIS COULD CAUSE INFECTION ((B)(4)). NO MEDICAL INTERVENTION WAS REPORTED. AS PER THE FOLLOW UP VIA PHONE ON 05MAY2022, IT WAS REPORTED THAT THE PATIENT PUTS A CLOTH BETWEEN THEIR LEG BAG AND SKIN TO HELP PREVENT IRRITATION AND THE VELCRO STRAPS WERE TOO HARD SHARP THAT IRRITATES ALSO . ALSO STATED THAT THE PATIENT RECENTLY HAD A URINARY TRACT INFECTION AND WAS PRESCRIBED WITH ANTIBIOTICS FROM THEIR DOCTOR . CUSTOMER PREFERRED INFECTION CONTROL FOLEY CATHETER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE LEG BAG VELCRO STRAPS WERE UNCOMFORTABLE (PCN-150719 AND PCN-150732), AND THE LEG BAGS WOULD STICK TO THE SKIN WHICH CAUSED PAIN WHEN STANDING UP AND DOWN (PCN-150719 AND PCN-150732). ALSO STATED THAT THERE WAS AN IRRITATION IN THE URINARY TRACT FROM THIS ISSUE AND THIS COULD CAUSE INFECTION (PCN-150719 AND PCN-150732). NO MEDICAL INTERVENTION WAS REPORTED. AS PER THE FOLLOW UP VIA PHONE ON 05MAY2022, IT WAS REPORTED THAT THE PATIENT PUTS A CLOTH BETWEEN THEIR LEG BAG AND SKIN TO HELP PREVENT IRRITATION AND THE VELCRO STRAPS WERE TOO HARD SHARP THAT IRRITATES ALSO . ALSO STATED THAT THE PATIENT RECENTLY HAD A URINARY TRACT INFECTION AND WAS PRESCRIBED WITH ANTIBIOTICS FROM THEIR DOCTOR . CUSTOMER PREFERRED INFECTION CONTROL FOLEY CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1723307 URINE COLLECTION DRAIN BAG UNKNOWN DRAIN BAG KNX C.R. BARD, INC. (COVINGTON) -1018233 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other