BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PEN NEEDLE

    MDR report key: 11369396 · Received February 23, 2021

    Report

    Report Number
    2243072-2021-00574
    Event Type
    Malfunction
    Date Received
    February 23, 2021
    Date of Event
    January 26, 2021
    Report Date
    April 26, 2021
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    PMA / PMN Number
    K182320
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: B.5. DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THAT 4 BD¿ PEN NEEDLE HAD NO INSULIN FLOW WHILE PRIMING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CONSUMER STATED, NO INSULIN FLOW WHEN PRIMING STATED, MORE THAN 8 PEN NEEDLES AFFECTED." D.1. MEDICAL DEVICE BRAND NAME: BD¿ PEN NEEDLE. D.3. MEDICAL DEVICE MANUFACTURER: BECTON DICKINSON AND CO. (DUN LAOGHAIRE). D.4. MEDICAL DEVICE CATALOG #: 320550. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: D.4. MEDICAL DEVICE LOT #: 320550, D.4. MEDICAL DEVICE EXPIRATION DATE: 5/31/2025, H.4. DEVICE MANUFACTURE DATE: 5/12/2020; D.4. MEDICAL DEVICE LOT #: UNKNOWN, D.4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN, H.4. DEVICE MANUFACTURE DATE: UNKNOWN. D.4. UNIQUE IDENTIFIER (UDI) #: (B)(4). D.10. DEVICE AVAILABLE FOR EVAL?: YES. D.10. RETURNED TO MANUFACTURER ON: 3/1/2021. G.1. MANUFACTURING LOCATION: BECTON DICKINSON AND CO. (DUN LAOGHAIRE). G.5. PMA / 510(K) #: K182320. H.6. INVESTIGATION: CUSTOMER RETURNED THREE PEN NEEDLES INSIDE THEIR CAPS AND SHIELDS ALONGSIDE A BOX LABELED FOR 4MM, 32 GAUGE PEN NEEDLES FROM LOT 0133297. ALL PEN NEEDLES WERE VISUALLY INSPECTED PRIOR TO TESTING FOR NEEDLE CLOGS. ALL THREE OF THE RETURNED PEN NEEDLES HAVE HAD THEIR CANNULAS BROKEN AT THE PROXIMAL END OF THE 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 NEEDLES 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. 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. BASED ON THE SAMPLE RECEIVED, BD¿S INVESTIGATION FOUND THAT ALL THREE RETURNED PEN NEEDLES 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 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 4 BD¿ PEN NEEDLE HAD NO INSULIN FLOW WHILE PRIMING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CONSUMER STATED, NO INSULIN FLOW WHEN PRIMING STATED, MORE THAN 8 PEN NEEDLES AFFECTED."

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 4 UNSPECIFIED BD¿ PEN NEEDLES HAD NO INSULIN FLOW WHILE PRIMING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CONSUMER STATED, NO INSULIN FLOW WHEN PRIMING STATED, MORE THAN 8 PEN NEEDLES AFFECTED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    265863 BD PEN NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1