BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA-FINE NANO PEN NEEDLES 4MM (5/32) 32G

    MDR report key: 10684760 · Received October 15, 2020

    Report

    Report Number
    9616656-2020-01025
    Event Type
    Malfunction
    Date Received
    October 15, 2020
    Date of Event
    September 22, 2020
    Report Date
    October 30, 2020
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    UDI-DI
    10885403928659
    PMA / PMN Number
    K162516
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    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: 10/23/2020. H.6. INVESTIGATION: CUSTOMER RETURNED FOUR (4) UNUSED 32GX4MM BD PEN NEEDLES FROM LOT 9113867. IT WAS REPORTED THAT THE CONSUMER ATTACHES THE PEN NEEDLES TO HIS INSULIN PEN AND NOTHING COMES OUT. ALL 4 RETURNED PEN NEEDLES WERE EXAMINED, THEN TESTED FOR FLOW USING A TEST PEN INJECTOR: ALL 4 PEN NEEDLES WERE ABLE TO EXPEL PROPERLY. NO EVIDENCE OF MANUFACTURING DEFECT WAS OBSERVED. SINCE NO DEFECTS WERE OBSERVED, THE ALLEGED ISSUE 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PEN NDL 32G 4MM 100BX 1200 USA WAS UNABLE TO DELIVER MEDICATION DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT THE CONSUMER ATTACHES THE PEN NEEDLES TO HIS INSULIN PEN AND NOTHING COMES OUT. VERBATIM: FROM PHONE CALL ON 2020-09-22 14:14:01: RETURNED CONSUMER'S PHONE CALL FROM VOICEMAIL THAT WAS RECEIVED. CONSUMER STATED HE HAS 2-3 PEN NEEDLES FROM EVERY BOX THAT HE GETS, THAT DON'T RELEASE HIS MEDICATION. STATED HE ATTACHES THE PEN NEEDLES TO HIS INSULIN PEN AND NOTHING COMES OUT."

    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 32 G 4 MM 100BX 1200 USA WAS UNABLE TO DELIVER MEDICATION DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT THE CONSUMER ATTACHES THE PEN NEEDLES TO HIS INSULIN PEN AND NOTHING COMES OUT. VERBATIM: FROM PHONE CALL ON (B)(6) 2020 14:14:01: RETURNED CONSUMER'S PHONE CALL FROM VOICEMAIL THAT WAS RECEIVED. CONSUMER STATED HE HAS 2-3 PEN NEEDLES FROM EVERY BOX THAT HE GETS, THAT DON'T RELEASE HIS MEDICATION. STATED HE ATTACHES THE PEN NEEDLES TO HIS INSULIN PEN AND NOTHING COMES OUT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1152663 BD ULTRA-FINE NANO PEN NEEDLES 4MM (5/32) 32G HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 2865 9113867 10885403928659

    Patients

    Seq Age Sex Outcome Treatment
    1 Other