BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEN NDL 32G 4MM HP

    MDR report key: 11227335 · Received January 25, 2021

    Report

    Report Number
    9616656-2021-00065
    Event Type
    Malfunction
    Date Received
    January 25, 2021
    Date of Event
    January 4, 2021
    Report Date
    February 5, 2021
    Manufacturer
    BECTON DICKINSON AND CO.
    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

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES. D10: RETURNED TO MANUFACTURER ON: 2021-02-11. H6: INVESTIGATION SUMMARY: TWENTY SIX SEALED AND INTACT 32G X 4MM PEN NEEDLE SAMPLES WERE RETURNED FROM LOT NO. 0133299, CAT. NO. 320562. VISUAL EXAMINATION WAS CARRIED OUT ON ALL TWENTY SIX SAMPLES AND NO ISSUES WERE OBSERVED. A LOT HISTORY REVIEW WAS CARRIED OUT AND NO RELATED NON CONFORMANCES WERE RAISED IN ASSOCIATION WITH THIS PACKAGED LOT CONCLUDING ALL INSPECTIONS WERE PERFORMED AS PER THE APPLICABLE OPERATIONS AND MET QC SPECIFICATIONS. NO ISSUES WERE OBSERVED ON THE RETURNED SAMPLES THEREFORE NO ROOT CAUSE CAN BE IDENTIFIED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PEN NDL 32G 4MM HP EXPERIENCED THE CANNULA BREAKING OFF/PULLING OUT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PHARMACY HAS EXPERIENCED NEEDLES THAT HAVE BROKEN OFF AT THE CARTRIDGE WHILE INJECTING INSULIN. LOT 0133299. REF 320562.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PEN NDL 32G 4MM HP EXPERIENCED THE CANNULA BREAKING OFF/PULLING OUT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PHARMACY HAS EXPERIENCED NEEDLES THAT HAVE BROKEN OFF AT THE CARTRIDGE WHILE INJECTING INSULIN. LOT: 0133299, REF:(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    121799 PEN NDL 32G 4MM HP PEN NEEDLE FMI BECTON DICKINSON AND CO. 0133299

    Patients

    Seq Age Sex Outcome Treatment
    1