BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEN NDL 32G 6MM 3B TW

    MDR report key: 9806799 · Received March 9, 2020

    Report

    Report Number
    9616656-2020-00194
    Event Type
    Malfunction
    Date Received
    March 9, 2020
    Date of Event
    February 17, 2020
    Report Date
    March 26, 2020
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY THIRTY NINE OPEN AND FIFTY FOUR SEALED 32G X 6MM PEN NEEDLE SAMPLES AND SIX PHOTOS WERE RETURNED FROM LOT. NO. 9121516, CAT. NO. 320738. VISUAL EXAMINATION WAS CARRIED OUT ON THE THIRTY NINE OPEN SAMPLES ALONG WITH THE FIFTY FOUR SEALED SAMPLES AND SIX PHOTOS AND NO ISSUES WERE OBSERVED. INVESTIGATION CONCLUSION VISUAL EXAMINATION WAS CARRIED OUT ON THE THIRTY NINE OPEN SAMPLES ALONG WITH THE FIFTY FOUR SEALED SAMPLES AND SIX PHOTOS 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 PER THE APPLICABLE OPERATIONS AND MET QC SPECIFICATIONS. ROOT CAUSE DESCRIPTION NO ISSUES WERE OBSERVED WITH THE RETURNED SAMPLES THEREFORE NO ROOT CAUSE CAN BE IDENTIFIED. RATIONALE BASED ON AN EVALUATION OF SEVERITY AND OCCURRENCE IT WAS DETERMINED THAT NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PEN NDL 32G 6MM 3B TW EXPERIENCED INNER SHIELD/OUTER COVER/CAP WOULD NOT DETACH AFTER USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE OUTER COVER WAS LOOSE AND HARD TO COME OFF. THE ISSUE DIDN'T OCCUR WHEN USING MFP31G HOWEVER THE ISSUE OCCURS AFTER CHANGING TO 32G6MM. THE PATIENT HAD NEEDLE STICK INJURY SOMETIMES.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PEN NDL 32G 6MM 3B TW EXPERIENCED INNER SHIELD/OUTER COVER/CAP WOULD NOT DETACH AFTER USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE OUTER COVER WAS LOOSE AND HARD TO COME OFF. THE ISSUE DIDN'T OCCUR WHEN USING MFP31G HOWEVER THE ISSUE OCCURS AFTER CHANGING TO 32G6MM. THE PATIENT HAD NEEDLE STICK INJURY SOMETIMES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    267792 PEN NDL 32G 6MM 3B TW PEN NEEDLE FMI BECTON DICKINSON AND CO. 9121516

    Patients

    Seq Age Sex Outcome Treatment
    1 Other