BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEN NDL 32G 4MM HP 100 BOX 1200 US

    MDR report key: 11718559 · Received April 23, 2021

    Report

    Report Number
    2243072-2021-01243
    Event Type
    Malfunction
    Date Received
    April 23, 2021
    Date of Event
    March 29, 2021
    Report Date
    May 11, 2021
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    UDI-DI
    00382903205509
    PMA / PMN Number
    K182320
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D4: MEDICAL DEVICE LOT #: 0203719. D4: MEDICAL DEVICE EXPIRATION DATE: 2025-07-31. H4: DEVICE MANUFACTURE DATE: 2020-07-21. D10: DEVICE AVAILABLE FOR EVAL YES. D10: RETURNED TO MANUFACTURER ON: 2021-05-05. H6: INVESTIGATION SUMMARY CUSTOMER RETURNED A TOTAL OF THREE PEN NEEDLES. ALL FEATURED GREEN INNER SHIELDS FOR 4MM, 32 GAUGE NEEDLES WITH ONE FEATURING ITS TEAR DROP LABEL IDENTIFYING ITS LOT AS 0203719. ALL PEN NEEDLES WERE VISUALLY INSPECTED PRIOR TO TESTING FOR NEEDLE CLOGS. ONE OF THE RETURNED PEN NEEDLES HAS HAD ITS CANNULA BROKEN ON THE NON-PATIENT SIDE AT THE PROXIMAL END OF HUB¿S NEEDLE CANNULA. THIS WOULD PREVENT NORMAL TESTING FOR CLOGS. ADDITIONALLY, THIS DAMAGE WOULD PREVENT THE NEEDLE FROM PROPERLY ATTACHING TO THE PEN, GIVING THE IMPRESSION THAT THE NEEDLE WAS CLOGGED DURING USE. BASED ON THE DAMAGE PRESENT, THE NEEDLE BREAKING MAY HAVE OCCURRED ACCIDENTALLY WHILE THE USER WAS PREPARING THE PEN NEEDLE FOR USE, POTENTIALLY IF THE PEN WAS NOT PROPERLY ALIGNED WITH THE CANNULA. THE REMAINING TWO PEN NEEDLES WERE ATTACHED TO A TEST PEN FILLED WITH SALINE. THE PEN WAS PRIMED AND SALINE WAS PUSHED THROUGH THE SYSTEM. THESE PEN NEEDLES FUNCTIONED AS INTENDED. A LOT HISTORY REVIEW WAS CARRIED OUT FOR LOT# 0203719 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 DHR REVIEW COULD BE DONE FOR THE UNKNOWN LOT NUMBER. BASED ON THE SAMPLE RECEIVED, BD¿S INVESTIGATION FOUND THAT THE PEN NEEDLE IN QUESTION HAD FRACTURED, WHICH COULD RESEMBLE THE NEEDLE BEING CLOGGED AS A RESULT OF INSULIN NOT PASSING THROUGH THE NEEDLE. THE ROOT CAUSE OF THE NEEDLES BENDING OR BREAKING APPEARS TO BE ACCIDENTAL DAMAGE FROM STRESSES CAUSED BY THE USER DURING ROUTINE USE. THIS WOULD HAVE ALSO GIVEN THE IMPRESSION THAT THE NEEDLE WAS CLOGGED SINCE INSULIN WOULD BE UNABLE TO PASS THROUGH THE CANNULA.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PEN NDL 32G 4MM HP 100 BOX 1200 US WAS UNABLE TO DELIVER MEDICATION DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT THERE IS NO INSULIN FLOW DURING INJECTION. VERBATIM: SPOUSE OF CONSUMER REPORTED, NO INSULIN FLOW WHEN TAKING INJECTION".

    Additional Manufacturer Narrative · 1

    ADDITIONAL INITIAL REPORTER PHONE: (B)(6). UNKNOWN MANUFACTURER: THERE ARE MULTIPLE BD LOCATIONS WHERE THIS UNSPECIFIED BD DEVICE MAY HAVE BEEN MANUFACTURED. A CATALOG AND LOT NUMBER COULD NOT BE CONFIRMED FOR THIS INCIDENT AND WITHOUT THIS INFORMATION WE ARE UNABLE TO DETERMINE WHERE THE DEVICE WAS MANUFACTURED. THEREFORE, (B)(4) HAS BEEN LISTED AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PEN NDL 32G 4MM HP 100 BOX 1200 US WAS UNABLE TO DELIVER MEDICATION DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT THERE IS NO INSULIN FLOW DURING INJECTION. VERBATIM: SPOUSE OF CONSUMER REPORTED, NO INSULIN FLOW WHEN TAKING INJECTION"

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    612628 PEN NDL 32G 4MM HP 100 BOX 1200 US HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON 320550 0203719 00382903205509

    Patients

    Seq Age Sex Outcome Treatment
    1