BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEN NDL 32G 4MM HP

    MDR report key: 15272388 · Received August 22, 2022

    Report

    Report Number
    9616656-2022-00882
    Event Type
    Malfunction
    Date Received
    August 22, 2022
    Date of Event
    August 3, 2022
    Report Date
    August 26, 2022
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS PENDING BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    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: 19-AUG-2022. H.6. INVESTIGATION SUMMARY: EIGHTY SEALED 32G X 4MM PEN NEEDLE SAMPLES WERE RETURNED FROM LOT. NO. 1152251, CAT. NO. 320658. A CLOG TEST WAS CARRIED OUT ON THIRTY OF THE RETURNED SAMPLES AS PER Q-SOP-183-DL AND NO ISSUES WERE OBSERVED. 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. NO ISSUES WERE OBSERVED ON THE RETURNED SAMPLES THEREFORE NO ROOT CAUSE CAN BE IDENTIFIED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 1 PEN NDL 32G 4MM HP NEEDLE WAS UNABLE OR DIFFICULT TO PRIME. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER : CHANGING NEEDLES. CUSTOMER CLAIMED THAT THERE ARE MANY NEEDLES WHO THE INSULIN DON'T COME OUT - BEFORE PUNCHING SHE TRIED IT - ALSO SHE THINKS THAT HIS PEN WAS BROKEN, BUT IT WAS THE NEEDLE WHO IS DEFECTIVE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 1 PEN NDL 32G 4MM HP NEEDLE WAS UNABLE OR DIFFICULT TO PRIME. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER : CHANGING NEEDLES. CUSTOMER CLAIMED THAT THERE ARE MANY NEEDLES WHO THE INSULIN DON'T COME OUT - BEFORE PUNCHING SHE TRIED IT - ALSO SHE THINKS THAT HIS PEN WAS BROKEN, BUT IT WAS THE NEEDLE WHO IS DEFECTIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2451202 PEN NDL 32G 4MM HP NEEDLE, HYPODERMIC, SINGLE LUMEN FMI BECTON DICKINSON AND CO. 1152251

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown