BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MICRO-FINE¿+ PEN NEEDLE

    MDR report key: 13743682 · Received March 12, 2022

    Report

    Report Number
    9616656-2022-00293
    Event Type
    Malfunction
    Date Received
    March 12, 2022
    Date of Event
    February 28, 2022
    Report Date
    April 19, 2022
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: UNKNOWN. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. MEDICAL DEVICE LOT #: 0266089. MEDICAL DEVICE EXPIRATION DATE: 2025-09-30 . DEVICE MANUFACTURE DATE: 2020-09-22. MEDICAL DEVICE LOT #: 1082104. MEDICAL DEVICE EXPIRATION DATE: 2026-03-31 . DEVICE MANUFACTURE DATE: 2021-03-23.

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: ONE OPEN 32G X 4MM PEN NEEDLE SAMPLE FROM LOT NO. 1082104, CAT. NO. 320136, TWO OPEN 32G X 4MM PEN NEEDLE SAMPLES FROM LOT NO. 0266089, CAT. NO. 320136 AND 43 OPEN 32G X 4MM PEN NEEDLE SAMPLES FROM AN UNKNOWN LOT. NO. WERE RETURNED ALONG WITH SIX PHOTOS. VISUAL EXAMINATION WAS CARRIED OUT ON THE RETURNED SAMPLES AND PHOTOS AND A BENT NON PATIENT END OF CANNULA WAS OBSERVED ON THE ONE OPEN SAMPLE FROM LOT. NO. 1082104 THE TWO OPEN SAMPLES FROM LOT NO. 0266089 AND THIRTY ONE SAMPLES FROM AN UNKNOWN LOT NO. A CLOG TEST AS PER Q-SOP-183-DL WAS CARRIED OUT ON THE REMAINING TWELVE SAMPLES FROM AN UNKNOWN LOT. NO. 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. AS ALL SAMPLES RETURNED WERE OPEN IT IS NOT POSSIBLE TO CONFIRM THIS DEFECT TO BE MANUFACTURING RELATED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 4 BD MICRO-FINE¿+ PEN NEEDLES WERE UNABLE TO PRIME. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE PATIENT COMPLAINS THAT THE DRUG SOLUTION DIDN'T COME OUT UPON PRIMING.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 4 BD MICRO-FINE¿+ PEN NEEDLES WERE UNABLE TO PRIME. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE PATIENT COMPLAINS THAT THE DRUG SOLUTION DIDN'T COME OUT UPON PRIMING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1151260 BD MICRO-FINE¿+ PEN NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown