BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEN NDL 32GA 4MM 100 BX 1200 CA

    MDR report key: 10832960 · Received November 12, 2020

    Report

    Report Number
    9616656-2020-01124
    Event Type
    Malfunction
    Date Received
    November 12, 2020
    Date of Event
    October 19, 2020
    Report Date
    January 8, 2021
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVAL?: YES. D.10. RETURNED TO MANUFACTURER ON: 10/19/2020. H.6. INVESTIGATION: CUSTOMER RETURNED TWO (2) UNUSED 32GX4MM BD PEN NEEDLES FROM LOT 9121965. CONSUMER REPORTED THAT HIS SKIN IS TEARING WITH EVERY PEN NEEDLE DURING THE INJECTION, THAT THE NEEDLE IS FLATTENED AT THE TIP, AND PEN NEEDLES ARE RESTRICTING DURING HIS INJECTIONS. BOTH PEN NEEDLES WERE EXAMINED, THEN TESTED FOR VISUAL INSPECTION OF POINT GEOMETRY, OUTER DIAMETER AND LUBE COVERAGE, THEN TESTED FOR FLOW USING A TEST PEN INJECTOR. BOTH PEN NEEDLES TESTED WITHIN POINT GEOMETRY, OUTER DIAMETER AND LUBE COVERAGE SPECIFICATION. BOTH WERE ABLE TO ATTACH TO THE PEN INJECTOR AND EXPEL PROPERLY. NO EVIDENCE OF MANUFACTURING DEFECT WAS OBSERVED. SINCE NO DEFECTS WERE OBSERVED THE ALLEGED ISSUES COULD NOT BE CONFIRMED. 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. ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PEN NDL 32GA 4MM 100 BX 1200 CA WAS UNABLE TO DELIVER MEDICATION DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT THE NEEDLE IS FLATTENED AT THE TIP AND HIS SKIN IS TEARING WITH EVERY PEN NEEDLE DURING THE INJECTION. VERBATIM: (B)(6) 2020: PER RCC REQUEST, CALLED CONSUMER TO OBTAIN CLARITY ON WHAT HE MEANT WHEN HE STATED THE NEEDLES ARE "RESTRICTING" HOWEVER, CONSUMER DID NOT ANSWER. LEFT VM WITH BD CARES PHONE NUMBER FOR CALL BACK. LG FROM PHONE CALL ON (B)(6) 202012:26:34: CONSUMER RETURNED CALL FROM VOICEMAIL HE RECEIVED FROM REP. STATED HE FEELS THE PEN NEEDLES ARE RESTRICTING DURING HIS INJECTIONS. STATED IT'S LIKE HIS SKIN IS TEARING WITH EVERY PEN NEEDLES DURING INJECTIONS. STATED THIS HAS ALSO HAPPENED WITH PREVIOUS BOXES. VOICEMAIL: CONSUMER LEFT VOICEMAIL STATING THAT THE NEEDLE IS FLATTENED ON THE TIP. (B)(6) 2020: I RETURNED CONSUMER'S CALL AND LEFT A VOICEMAIL FOR RETURN CALL."

    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PEN NDL 32GA 4MM 100 BX 1200 CA WAS UNABLE TO DELIVER MEDICATION DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT THE NEEDLE IS FLATTENED AT THE TIP AND HIS SKIN IS TEARING WITH EVERY PEN NEEDLE DURING THE INJECTION. VERBATIM: (B)(6) 2020: PER RCC REQUEST, CALLED CONSUMER TO OBTAIN CLARITY ON WHAT HE MEANT WHEN HE STATED THE NEEDLES ARE "RESTRICTING" HOWEVER, CONSUMER DID NOT ANSWER. LEFT VM WITH BD CARES PHONE NUMBER FOR CALL BACK. LG FROM PHONE CALL ON (B)(6) 2020 12:26:34: CONSUMER RETURNED CALL FROM VOICEMAIL HE RECEIVED FROM REP. STATED HE FEELS THE PEN NEEDLES ARE RESTRICTING DURING HIS INJECTIONS. STATED IT'S LIKE HIS SKIN IS TEARING WITH EVERY PEN NEEDLES DURING INJECTIONS. STATED THIS HAS ALSO HAPPENED WITH PREVIOUS BOXES. VOICEMAIL: CONSUMER LEFT VOICEMAIL STATING THAT THE NEEDLE IS FLATTENED ON THE TIP. (B)(6) 2020: I RETURNED CONSUMER'S CALL AND LEFT A VOICEMAIL FOR RETURN CALL."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1298070 PEN NDL 32GA 4MM 100 BX 1200 CA HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 9121965

    Patients

    Seq Age Sex Outcome Treatment
    1