BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEN NDL 32GA 4MM 14BAG 700CASE JP

    MDR report key: 11742819 · Received April 28, 2021

    Report

    Report Number
    9616656-2021-00448
    Event Type
    Malfunction
    Date Received
    April 28, 2021
    Date of Event
    April 1, 2021
    Report Date
    June 4, 2021
    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

    Narratives

    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: 4/14/2021. H.6. INVESTIGATION: ONE OPEN 32G X 4MM PEN NEEDLE SAMPLE AND TWO PHOTOS WERE RETURNED FROM LOT. NO. 0203701, CAT. NO.320136. VISUAL EXAMINATION WAS CARRIED OUT ON THE RETURNED SAMPLE AND PHOTOS AND DAMAGE TO THE HUB WAS 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. THIS ISSUE WAS CAUSED BY AN INTERFERENCE FIT BETWEEN THE HUB AND COVER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PEN NDL 32GA 4MM 14BAG 700CASE JP DID NOT ATTACH DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "THE CUSTOMER REPORTED THAT THE PATIENT COULD NOT ATTACH THE PEN NEEDLE TO THE PEN (POSSIBLY DUE TO A SCREW THREAD-RELATED DEFECT)."

    Additional Manufacturer Narrative · 1

    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 A PEN NDL 32GA 4MM 14BAG 700CASE JP DID NOT ATTACH DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "THE CUSTOMER REPORTED THAT THE PATIENT COULD NOT ATTACH THE PEN NEEDLE TO THE PEN (POSSIBLY DUE TO A SCREW THREAD-RELATED DEFECT)."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    632643 PEN NDL 32GA 4MM 14BAG 700CASE JP HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 0203701

    Patients

    Seq Age Sex Outcome Treatment
    1