BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE 30GX1/2 IN FOR PHARM CUSTOMERS

    MDR report key: 11682735 · Received April 16, 2021

    Report

    Report Number
    3002682307-2021-00140
    Event Type
    Malfunction
    Date Received
    April 16, 2021
    Date of Event
    March 17, 2021
    Report Date
    April 20, 2021
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBERS 180413 AND 191020. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. TO AID IN THE INVESTIGATION OF THIS ISSUE, THREE PICTURE SAMPLES WERE RETURNED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. THE PICTURES WERE EXAMINED AND THE CANNULA WAS OBSERVED CROSSING THROUGH THE SHIELD COMPONENT. BASED ON THE INVESTIGATION RESULTS AND THE PROVIDED FEEDBACK, WE HAVE CONCLUDED THAT THIS INCIDENT RESULTED DUE TO A BENT NEEDLE AND THE CANNULA BECOMING EMBEDDED WITHIN THE SHIELD AS CONSEQUENCE. THIS TYPE OF DAMAGE COULD OCCUR IN THE LAST STEPS OF THE ASSEMBLY PROCESS, WHERE THE SHIELD IS INTRODUCED TO THE SYRINGE. DUE TO AN INSUFFICIENT ADJUSTMENT IN THE ASSEMBLY MACHINE, THE SHIELD WAS INCORRECTLY POSITIONED AND BENT THE CANNULA COMPONENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT NEEDLE 30GX1/2 IN FOR PHARM CUSTOMERS POKED THE CONSUMER FROM INSIDE THE PACKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: COMPLAINANT WAS STABBED IN THE FINGER BY A NEEDLE INSIDE THE PACKAGE.

    Additional Manufacturer Narrative · 1

    MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 191020 MEDICAL DEVICE EXPIRATION DATE: 2024-09-30 DEVICE MANUFACTURE DATE: 2019-10-29. MEDICAL DEVICE LOT #: 180413 MEDICAL DEVICE EXPIRATION DATE: 2023-03-31 DEVICE MANUFACTURE DATE: 2018-04-04. 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 30GX1/2 IN FOR PHARM CUSTOMERS POKED THE CONSUMER FROM INSIDE THE PACKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: COMPLAINANT WAS STABBED IN THE FINGER BY A NEEDLE INSIDE THE PACKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    577937 NEEDLE 30GX1/2 IN FOR PHARM CUSTOMERS NEEDLE FMI BECTON DICKINSON, S.A. SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1