BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MALE EXTERNAL CATHETER

    MDR report key: 11657348 · Received April 13, 2021

    Report

    Report Number
    1018233-2021-02089
    Event Type
    Malfunction
    Date Received
    April 13, 2021
    Date of Event
    March 20, 2021
    Report Date
    May 7, 2021
    Manufacturer
    C.R. BARD, INC. (COVINGTON) -1018233
    Product Code
    NNX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED ISSUE WAS INCONCLUSIVE AS NO SAMPLE WAS RETURNED FOR EVALUATION. A POTENTIAL ROOT CAUSE FOR THIS FAILURE COULD BE DUE TO ¿VISCOMETER FAILURE OR MECHANICAL FAILURE". IT WAS UNKNOWN WHETHER THE DEVICE HAD MET SPECIFICATIONS. THE PRODUCT WAS USED FOR TREATMENT BUT IT WAS UNKNOWN WHETHER THE PRODUCT HAD CAUSED THE REPORTED FAILURE. THE DEVICE HISTORY REVIEW COULD NOT BE PERFORMED WITHOUT A LOT NUMBER. THE PRODUCT CATALOG NUMBER AND LOT NUMBER FOR THIS DEVICE IS UNKNOWN. THEREFORE, BARD IS UNABLE TO DETERMINE THE ASSOCIATED LABELING TO REVIEW. 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 LAST BATCH OF MALE EXTERNAL CATHETER HAD LITTLE ADHESIVE AND CAUSED ROLL OFF DURING MID FLOW. STATED THAT IT CAUSED A MESS AND NEEDED SOMEONE ELSE TO CLEAN UP. ALSO STATED THAT SOME MALE EXTERNAL CATHETER HAD TOO MUCH ADHESIVE AND THE BABY OIL WAS USED TO REMOVE IT.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LAST BATCH OF MALE EXTERNAL CATHETER HAD LITTLE ADHESIVE AND CAUSED ROLL OFF DURING MID FLOW. STATED THAT IT CAUSED A MESS AND NEEDED SOMEONE ELSE TO CLEAN UP. ALSO STATED THAT SOME MALE EXTERNAL CATHETER HAD TOO MUCH ADHESIVE AND THE BABY OIL WAS USED TO REMOVE IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    552316 MALE EXTERNAL CATHETER UNKNOWN MALE EXTERNAL CATHETER NNX C.R. BARD, INC. (COVINGTON) -1018233 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other