BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IRRIG-BULK/CLEAN 100

    MDR report key: 11942438 · Received June 4, 2021

    Report

    Report Number
    1018233-2021-03254
    Event Type
    Malfunction
    Date Received
    June 4, 2021
    Date of Event
    May 13, 2021
    Report Date
    November 17, 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
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT WAS CONFIRMED CAUSE UNKNOWN. 1 SAMPLE WAS CONFIRMED TO EXHIBIT THE REPORTED FAILURE. THE DEVICE HAD NOT MET SPECIFICATIONS. THE PRODUCT WAS USED FOR TREATMENT. THE PRODUCT CAUSED THE REPORTED FAILURE. VISUAL EVALUATION OF THE RETURNED SAMPLE NOTED ONE OPENED (WITHOUT ORIGINAL PACKAGING), USED IRRIGATION BULB SYRINGE. VISUAL INSPECTION OF THE SAMPLE NOTED THAT THERE WAS A GNAT, WHICH WAS LARGER THAN 0.6 SQ MM, WITHIN THE BARREL OF THE SYRINGE. THIS DOES NOT MEET THE SPECIFICATION "LOOSE OR EMBEDDED FOREIGN MATTER GREATER THAN 0.6MM2 OR 1/16¿ IN LENGTH IS NOT PERMITTED. (3 PARTICLES MAXIMUM PER SIDE OR SURFACE). PER TAPPI DIRT ESTIMATION CHART." PER IP7600403, REVISION 9. A POTENTIAL ROOT CAUSE FOR THIS FAILURE COULD BE ¿NO FOLLOW UP TO THE PRODUCTION AREAS CLEANING PROCEDURE.¿ A REVIEW OF THE DEVICE HISTORY RECORD DID NOT SHOW ANY PROBLEMS OR CONDITIONS THAT WOULD HAVE CONTRIBUTED TO THE REPORTED ISSUE. THEREFORE, NO ADDITIONAL ACTION IS REQUIRED AT THIS TIME. 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 LABELLING COULD NOT HAVE PREVENTED THE REPORTED FAILURE. THE ACTUAL/SUSPECTED DEVICE WAS INSPECTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE GNAT WAS INSIDE AN ASEPTO BULBE SYRINGE.

    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 GNAT INSIDE AN ASEPTO BULBE SYRINGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    837560 IRRIG-BULK/CLEAN 100 ASEPTO BULBE SYRINGE KYZ C.R. BARD, INC. (COVINGTON) -1018233 0935280 NGEY0624 10801741051378

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other