BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEN NDL 32G 4MM 100BX 1200 USA

    MDR report key: 11264058 · Received February 1, 2021

    Report

    Report Number
    9616656-2021-00096
    Event Type
    Malfunction
    Date Received
    February 1, 2021
    Date of Event
    January 12, 2021
    Report Date
    March 4, 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
    WI, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY : NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. 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 AN UNSPECIFIED NUMBER OF PEN NDL 32G 4MM 100BX 1200 USA WERE UNABLE TO DELIVER MEDICATION DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT THE PEN NEEDLES DID NOT RELEASE INSULIN. VERBATIM: CONSUMER REPORTED HAVING PEN NEEDLES THAT DID NOT RELEASE INSULIN DURING PRIMING. STATED HER DIETICIAN ALSO TRIED AND THE PEN NEEDLES DID NOT RELEASE MEDICATION. CONSUMER STATED SHE WAS ADVISED THAT IT IS AN ISSUE WITH HER NEEDLES. ALSO STATED HER DIETICIAN ADVISED HER TO CALL BD FOR A REPLACEMENT. LOT#0022083 CAT# 320122DATE OF EVENT: UNKNOWN SAMPLES: NO".

    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 AN UNSPECIFIED NUMBER OF PEN NDL 32G 4MM 100BX 1200 USA WERE UNABLE TO DELIVER MEDICATION DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT THE PEN NEEDLES DID NOT RELEASE INSULIN. VERBATIM: CONSUMER REPORTED HAVING PEN NEEDLES THAT DID NOT RELEASE INSULIN DURING PRIMING. STATED HER DIETICIAN ALSO TRIED AND THE PEN NEEDLES DID NOT RELEASE MEDICATION. CONSUMER STATED SHE WAS ADVISED THAT IT IS AN ISSUE WITH HER NEEDLES. ALSO STATED HER DIETICIAN ADVISED HER TO CALL BD FOR A REPLACEMENT. LOT#0022083, CAT# 320122 DATE OF EVENT: UNKNOWN SAMPLES: NO."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    153519 PEN NDL 32G 4MM 100BX 1200 USA HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 320122 0022083 00382903201228

    Patients

    Seq Age Sex Outcome Treatment
    1