BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEN NDL 32G 4MM 100BX 1200 USA

    MDR report key: 11477692 · Received March 12, 2021

    Report

    Report Number
    9616656-2021-00254
    Event Type
    Malfunction
    Date Received
    March 12, 2021
    Date of Event
    February 14, 2021
    Report Date
    April 12, 2021
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    UDI-DI
    00382903201228
    PMA / PMN Number
    K162516
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: CUSTOMER RETURNED THREE PEN NEEDLE OUTER COVERS, ONE INNER SHIELD, AND TWO PEN NEEDLE HUBS. THE OUTER COVERS DID NOT FEATURE ANY OBSERVABLE DAMAGE. THE HUBS RETURNED FIT IN THE COVERS AND WOULD NOT FALL OUT WHEN SECURED INSIDE OF THEM. COVERS APPEAR TO BE WORKING AS INTENDED. THE CANNULAS OF THE PEN NEEDLES WERE BOTH BENT TO ONE SIDE. THIS MAY HAVE BEEN THE RESULT OF STRESSES APPLIED AFTER THE INNER SHIELD WAS REMOVED FROM THE NEEDLE. WITH ONE INNER SHIELD ALREADY REMOVED AND THE OTHER MISSING, NO TESTING CAN BE PERFORMED TO MEASURE THE FORCE REQUIRED TO REMOVE THE SHIELDS FROM THE HUBS. THE RETURNED INNER SHIELD DOES NOT FEATURE ANY OBSERVABLE DAMAGE. BASED ON THE SAMPLES RECEIVED, BD WAS ABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE OF NEEDLES BENDING. BD WAS UNABLE TO DIRECTLY REPLICATE OR CONFIRM THE REPORT OF THE INNER SHIELDS SEPARATING FROM THE NEEDLE HUBS. BD WAS UNABLE TO DIRECTLY CONFIRM THE CUSTOMER¿S INDICATED FAILURE OF A NEEDLE STICK. BD WAS UNABLE TO DIRECTLY REPLICATE OR CONFIRM THE REPORT OF THE OUTER COVER SEPARATING. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PEN NDL 32G 4MM 100BX 1200 USA NEEDLE SHIELDS WERE OFF OR LOOSE INSIDE THE BAG. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 320122 BATCH. NO. 0063208. IT WAS REPORTED THAT NEEDLE SHIELDS WERE OFF SYRINGES AND LOOSE IN BAG. NEEDLES WITHOUT SHIELDS WERE BENT AND CONSUMER RECEIVED NEEDLE STICK WHEN REACHING INTO THE BOX. VERBATIM: JUST WANTING TO PASS ON SOME ISSUES I HAVE EXPERIENCED WITH MY LATEST SUPPLY OF YOUR DB NANO ULTRA FINE NEEDLES. IN MY CURRENT BOX OF 100 NEEDLES I HAVE FOUND: SEVERAL EMPTY CAPS. SEVERAL LOOSE NEEDLES WITH BENT TIPS ( BECAUSE THEY WERE UNPROTECTED.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 PEN NDL 32G 4MM 100BX 1200 USA NEEDLE SHIELDS WERE OFF OR LOOSE INSIDE THE BAG. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 320122, BATCH NO. 0063208. IT WAS REPORTED THAT NEEDLE SHIELDS WERE OFF SYRINGES AND LOOSE IN BAG. NEEDLES WITHOUT SHIELDS WERE BENT AND CONSUMER RECEIVED NEEDLE STICK WHEN REACHING INTO THE BOX. VERBATIM: JUST WANTING TO PASS ON SOME ISSUES I HAVE EXPERIENCED WITH MY LATEST SUPPLY OF YOUR DB NANO ULTRA FINE NEEDLES. IN MY CURRENT BOX OF 100 NEEDLES I HAVE FOUND: SEVERAL EMPTY CAPS. SEVERAL LOOSE NEEDLES WITH BENT TIPS ( BECAUSE THEY WERE UNPROTECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    366792 PEN NDL 32G 4MM 100BX 1200 USA HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 320122 0063208 00382903201228

    Patients

    Seq Age Sex Outcome Treatment
    1