BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE IRRIGATION BULK / CLEAN, 50ML

    MDR report key: 11885468 · Received May 26, 2021

    Report

    Report Number
    1018233-2021-03028
    Event Type
    Malfunction
    Date Received
    May 26, 2021
    Date of Event
    April 27, 2021
    Report Date
    November 19, 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 HOWEVER THE CAUSE WAS UNKNOWN. 1 SAMPLE WAS CONFIRMED TO EXHIBIT THE REPORTED FAILURE. THE DEVICE HAD NOT MET SPECIFICATIONS. THE PRODUCT WAS NOT USED FOR TREATMENT 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 HAIR BETWEEN THE BULB AND SYRINGE. THIS DOES NOT MEET THE SPECIFICATION "NO HAIR IS PERMITTED ON THE PRODUCT." THE PRODUCT CAUSED THE REPORTED FAILURE. A POTENTIAL ROOT CAUSE FOR THIS FAILURE COULD BE ¿NO FOLLOW UP TO THE PRODUCTION AREAS CLEANING PROCEDURE." 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. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BLACK HAIR WAS FOUND IN BETWEEN BULB AND ASEPTO 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 BLACK HAIR WAS FOUND IN BETWEEN BULB AND ASEPTO SYRINGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    784396 SYRINGE IRRIGATION BULK / CLEAN, 50ML BULB SYRINGE KYZ C.R. BARD, INC. (COVINGTON) -1018233 0935280 NGEY0624 10801741051378

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other