BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEN NDL 32G 4MM HP 100 BOX 1200 US

    MDR report key: 11586624 · Received March 29, 2021

    Report

    Report Number
    9616656-2021-00330
    Event Type
    Malfunction
    Date Received
    March 29, 2021
    Date of Event
    March 3, 2021
    Report Date
    April 22, 2021
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    UDI-DI
    00382903205509
    PMA / PMN Number
    K182320
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: 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. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PEN NDL 32G 4MM HP 100 BOX 1200 US LEAKED. THIS OCCURRED ON 6 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO:320550 BATCH NO: 0133297 IT WAS REPORTED THAT THERE IS LEAKAGE WHEN TAKING THE INJECTION. VERBATIM: CONSUMER REPORTED, LEAKAGE WHEN TAKING INJECTION. STATED, SHE DOES NOT PRIME BEFORE TAKING INJECTION BECAUSE THAT WILL WASTE HER INSULIN. STATED, SHE DOES NOT LIKE THE NEW 2ND GEN AND WILL BE SWITCHING TO ANOTHER BRAND. WENT OVER INSTRUCTION ON HOW TO USE, CONSUMER WAS NOT INTERESTED. REQUESTED REFUND INSTEAD OF REPLACEMENT.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PEN NDL 32G 4MM HP 100 BOX 1200 US LEAKED. THIS OCCURRED ON 6 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO:320550, BATCH NO: 0133297. IT WAS REPORTED THAT THERE IS LEAKAGE WHEN TAKING THE INJECTION. VERBATIM: CONSUMER REPORTED, LEAKAGE WHEN TAKING INJECTION. STATED, SHE DOES NOT PRIME BEFORE TAKING INJECTION BECAUSE THAT WILL WASTE HER INSULIN. STATED, SHE DOES NOT LIKE THE NEW 2ND GEN AND WILL BE SWITCHING TO ANOTHER BRAND. WENT OVER INSTRUCTION ON HOW TO USE, CONSUMER WAS NOT INTERESTED. REQUESTED REFUND INSTEAD OF REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    480809 PEN NDL 32G 4MM HP 100 BOX 1200 US PEN NEEDLE FMI BECTON DICKINSON AND CO. 320550 0133297 00382903205509

    Patients

    Seq Age Sex Outcome Treatment
    1