BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEN NDL 32G 4MM PRO 14 BAG 700 CASE JPX

    MDR report key: 10243243 · Received July 7, 2020

    Report

    Report Number
    9616656-2020-00643
    Event Type
    Malfunction
    Date Received
    July 7, 2020
    Date of Event
    June 10, 2020
    Report Date
    July 15, 2020
    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: SIX OPEN 32G X 4MM PEN NEEDLE SAMPLES AND FOUR PHOTOS WERE RETURNED FROM LOT. NO. 9240215, CAT. NO. 320559. VISUAL EXAMINATION WAS CARRIED OUT ON THE RETURNED SAMPLES AND PHOTOS AND IT WAS OBSERVED THAT FOUR SAMPLES WERE BROKEN AT THE NON PATIENT END OF THE CANNULA AND TWO SAMPLES WERE BENT AT THE NON PATIENT END OF THE CANNULA. 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 THE SAMPLES IN THE RETURNED PHOTOS WERE OPEN IT IS NOT POSSIBLE TO CONFIRM THIS DEFECT TO BE MANUFACTURING RELATED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PEN NDL 32G 4MM PRO 14 BAG 700 CASE JPX NEEDLE BROKE OFF BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: 'CUSTOMER IS COMPLAINING THAT THIS IS A DEFECT OCCURRING DURING THE MANUFACTURING PROCESS. CUSTOMER IS SAYING THAT THE NEEDLE FLEXIBILITY IS WEAK."

    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PEN NDL 32G 4MM PRO 14 BAG 700 CASE JPX NEEDLE BROKE OFF BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: 'CUSTOMER IS COMPLAINING THAT THIS IS A DEFECT OCCURRING DURING THE MANUFACTURING PROCESS. CUSTOMER IS SAYING THAT THE NEEDLE FLEXIBILITY IS WEAK."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    707094 PEN NDL 32G 4MM PRO 14 BAG 700 CASE JPX HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 9240215

    Patients

    Seq Age Sex Outcome Treatment
    1 Other