BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE 21GA 1-1/2IN

    MDR report key: 10011970 · Received April 29, 2020

    Report

    Report Number
    3002682307-2020-00139
    Event Type
    Malfunction
    Date Received
    April 29, 2020
    Date of Event
    March 5, 2020
    Report Date
    May 8, 2020
    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 SUMMARY A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR PROVIDED LOT NUMBER 190919. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS REPORTED INCIDENT AND ALL INSPECTIONS WERE FOUND TO BE WITHIN SPECIFICATION. TO AID IN THE INVESTIGATION OF THIS ISSUE, ONE PICTURE SAMPLE WAS PROVIDED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. THROUGH EXAMINATION OF THE PICTURE, THE NEEDLE HUB WAS OBSERVED BROKEN AT THE PRESFIT COMPONENT (THE PLASTIC PART). TO FURTHER INVESTIGATE THIS ISSUE, TWENTY RETAINED SAMPLES OF THE SAME LOT NUMBER WERE OBTAINED FROM THE MANUFACTURING FACILITY. THE RETAINED SAMPLES WERE FUNCTIONALLY TESTED AND NO DEFECTS WERE OBSERVED. BASED ON THE INVESTIGATION RESULTS, A CAUSE FOR THIS REPORTED INCIDENT COULD NOT BE DETERMINED. IT IS IMPORTANT TO NOTE THAT THE NEEDLE SHOULD PUNCTURE THE STOPPER AT A 90 DEGREE ANGLE. OUR QUALITY TEAM WILL CONTINUE TO MONITOR THE PRODUCTION PROCESS FOR SIGNS OF THIS POTENTIAL DEFECT AND ANY EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT NEEDLE 21GA 1-1/2IN BROKE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THAT DAY, WHILE PREPARING MY HPD KIT, THE NEEDLE BROKE OFF IN THE SEPTUM OF THE VIAL. AS A RESULT, I CONTAMINATED MY WORKTOP AND THE INSIDE OF THE SEALED JAR. I MOVED THE ENTIRE PREPARATION TRAY AWAY TO PROTECT MYSELF AND TO BE ABLE TO PREPARE AN HPD KIT AGAIN.

    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 21GA 1-1/2IN BROKE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THAT DAY, WHILE PREPARING MY HPD KIT, THE NEEDLE BROKE OFF IN THE SEPTUM OF THE VIAL. AS A RESULT, I CONTAMINATED MY WORKTOP AND THE INSIDE OF THE SEALED JAR. I MOVED THE ENTIRE PREPARATION TRAY AWAY TO PROTECT MYSELF AND TO BE ABLE TO PREPARE AN HPD KIT AGAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    476044 NEEDLE 21GA 1-1/2IN NEEDLE FMI BECTON DICKINSON, S.A. 190919

    Patients

    Seq Age Sex Outcome Treatment
    1 Other