BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE IRRIGATION BULK / CLEAN, 50ML

    MDR report key: 12079161 · Received June 28, 2021

    Report

    Report Number
    1018233-2021-03846
    Event Type
    Malfunction
    Date Received
    June 28, 2021
    Date of Event
    May 28, 2021
    Report Date
    December 30, 2021
    Manufacturer
    C.R. BARD, INC. (COVINGTON) -1018233
    Product Code
    KYZ
    UDI-DI
    10801741051378
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT WAS CONFIRMED AS MANUFACTURING RELATED. THE DEVICE HAD NOT MET SPECIFICATIONS. THE PRODUCT HAD CAUSED THE REPORTED FAILURE. VISUAL EVALUATION OF THE RETURNED SAMPLE NOTED ONE OPENED (WITHOUT ORIGINAL PACKAGING), IRRIGATION SYRINGE BULB. VISUAL INSPECTION OF THE SAMPLE NOTED 1.50 MM SQ BLACK FOREIGN MATERIAL FOUND IN BETWEEN THE BULB AND THE BARREL. THIS IS OUT OF SPECIFICATION PER INSPECTION PROCEDURE, WHICH STATES, "LOOSE OR EMBEDDED FOREIGN MATTER GREATER THAN 0.6MM2 OR 1/16¿ IN LENGTH IS NOT PERMITTED." " A POTENTIAL ROOT CAUSE FOR THIS FAILURE COULD BE NO FOLLOW UP TO THE GOOD MANUFACTURING PRACTICES. THE DEVICE HISTORY RECORD WAS REVIEWED AND FOUND NOTHING THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. A LABELING REVIEW WAS NOT PERFORMED BECAUSE LABELING COULD NOT HAVE PREVENTED THE REPORTED FAILURE. 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 ACTUAL/SUSPECTED DEVICE WAS INSPECTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE ASEPTO BULB SYRINGE AND KIDNEY BASIN HAD BLACK SPECS IN IT.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. THE DEVICE WAS NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ASEPTO BULB SYRINGE AND KIDNEY BASIN HAD BLACK SPECS IN IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    976497 SYRINGE IRRIGATION BULK / CLEAN, 50ML BULB SYRINGE KYZ C.R. BARD, INC. (COVINGTON) -1018233 0935280 NGEY0582 10801741051378

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other