BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE 18GA 1-1/2IN SB TW

    MDR report key: 12014271 · Received June 16, 2021

    Report

    Report Number
    3002682307-2021-00262
    Event Type
    Malfunction
    Date Received
    June 16, 2021
    Date of Event
    May 19, 2021
    Report Date
    August 23, 2021
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 210205. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. TO AID IN THE INVESTIGATION OF THIS ISSUE, A PICTURE SAMPLE WAS RETURNED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. THE PICTURE WAS EXAMINED AND THREE WHITE POINTS COULD BE OBSERVED. WITHOUT THE PHYSICAL SAMPLE, IT WAS NOT POSSIBLE TO IDENTIFY THE ORIGIN OF THE FOREIGN MATTER OBSERVED. AT THIS TIME, AN EXACT CAUSE RELATED TO THE MANUFACTURING PROCESS COULD NOT BE DETERMINED FOR THIS INCIDENT. TAKING INTO ACCOUNT THE PREVENTIVE MEASURES IN PLACE DURING THE CANNULA MANUFACTURING PROCESS, IT IS UNLIKELY THAT CORING RESULTED DUE TO INSUFFICIENT DE-BURRING OF THE CANNULA. CANNULA INSPECTION IS PERFORMED FOR POINT CONDITIONS, CLEANLINESS, FLASHES, AND CLOGGED/CRASHED CANNULA. CANNULA MEASUREMENTS AND PENETRATION TESTS ARE ALSO PERFORMED. THE STOPPER MATERIAL AND THE TECHNIQUE USED TO PENETRATE THE VIAL COULD ALSO HAVE POTENTIAL IMPLICATIONS FOR THIS INCIDENT. THE NEEDLE SHOULD PENETRATE THE STOPPER AT A NINETY DEGREE ANGLE TO AVOID THE RISK OF CORING.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT NEEDLE 18GA 1-1/2IN SB TW HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN WE PRICK THE SEPTUM OF A VIAL, THERE IS CORING OF THE LATTER WHICH CREATES A PARTICLE IN THE SYRINGE. (CF IN PJ A SYRINGE WITH VISIBLE PARTICLES). THIS EVENT IS RECURRENT.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT NEEDLE 18GA 1-1/2IN SB TW HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN WE PRICK THE SEPTUM OF A VIAL, THERE IS CORING OF THE LATTER WHICH CREATES A PARTICLE IN THE SYRINGE. (CF IN PJ A SYRINGE WITH VISIBLE PARTICLES). THIS EVENT IS RECURRENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    906168 NEEDLE 18GA 1-1/2IN SB TW NEEDLE FMI BECTON DICKINSON, S.A. 210205

    Patients

    Seq Age Sex Outcome Treatment
    1