BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEN NDL 31GA 5MM

    MDR report key: 11872425 · Received May 24, 2021

    Report

    Report Number
    9616656-2021-00583
    Event Type
    Malfunction
    Date Received
    May 24, 2021
    Date of Event
    April 26, 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

    H.6. INVESTIGATION: TWO OPEN 31G X 5MM PEN NEEDLE SAMPLES AND FIVE PHOTOS WERE RETURNED FROM LOT. NO. 0203811, CAT. NO. 320129. VISUAL EXAMINATION WAS CARRIED OUT ON THE RETURNED SAMPLES AND PHOTOS AND IT WAS OBSERVED THAT THE HUBS ON BOTH SAMPLES WERE DAMAGED. DUE TO THE CONDITION THE SAMPLES WERE RETURNED NO FUNCTIONALITY TEST COULD BE CARRIED OUT. 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 MOST LIKELY OCCURRED DUE TO A JAM ON THE MACHINE DURING THE MANUFACTURING PROCESS. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PEN NDL 31GA 5MM EXPERIENCED 2 CASES OF PRODUCT DAMAGE WHILE STILL CONSIDERED OPERABLE, AND 2 CASES OF BEING DIFFICULT TO OPERATE OR NOT WORKING/FUNCTIONING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER REPORTED THAT THE PEN NEEDLE COULD NOT BE ATTACHED TO THE PEN BECAUSE THE HUB WAS DEFORMED.

    Additional Manufacturer Narrative · 1

    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 PEN NDL 31GA 5MM EXPERIENCED 2 CASES OF PRODUCT DAMAGE WHILE STILL CONSIDERED OPERABLE, AND 2 CASES OF BEING DIFFICULT TO OPERATE OR NOT WORKING/FUNCTIONING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER REPORTED THAT THE PEN NEEDLE COULD NOT BE ATTACHED TO THE PEN BECAUSE THE HUB WAS DEFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    768076 PEN NDL 31GA 5MM PEN NEEDLE FMI BECTON DICKINSON AND CO. 0203811

    Patients

    Seq Age Sex Outcome Treatment
    1