BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PEN NDL 31GA 5MM 14BAG 700CAS JP

    MDR report key: 8705145 · Received June 17, 2019

    Report

    Report Number
    9616656-2019-00540
    Event Type
    Malfunction
    Date Received
    June 17, 2019
    Date of Event
    May 29, 2019
    Report Date
    July 3, 2019
    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

    INVESTIGATION: ONE OPEN 31G X 5MM PEN NEEDLE SAMPLE AND THREE PHOTOS WERE RETURNED FROM LOT. NO. 8072970, CAT. NO. 320129. VISUAL EXAMINATION WAS CARRIED OUT ON THE RETURNED PHOTOS AND SAMPLE AND A BROKEN NON PATIENT END OF CANNULA WAS OBSERVED. DUE TO THE CONDITION THE SAMPLE WAS RETURNED NO CLOG TESTING 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 PER THE APPLICABLE OPERATIONS AND MET QC SPECIFICATIONS. IT IS BD¿S EXPERIENCE THAT THE NON-PATIENT END BREAKAGE AND BENDING IS DIRECTLY ASSOCIATED WITH THE PLACING OF THE NEEDLE ONTO THE PEN DEVICE BY THE USER. IF THE NON-PATIENT END OF THE NEEDLE IS NOT PLACED CENTRALLY TO THE PEN DEVICE, THEN INSTEAD OF THE NON-PATIENT END OF THE NEEDLE PIERCING THE RUBBER SEPTUM OF THE VIAL, IT HITS HARD MATERIAL AND CAN BE BENT/BROKEN WHEN FITTED TO THE PEN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE MEDICATION WAS UNABLE TO BE DELIVERED WITH A BD PEN NDL 31GA 5MM 14BAG 700CAS JP. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: DRUG DIDN'T COME OUT DURING AIR PURGE.

    Additional Manufacturer Narrative · 1

    A SAMPLE IS AVAILABLE FOR EVALUATION. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE MEDICATION WAS UNABLE TO BE DELIVERED WITH A BD PEN NDL 31GA 5MM 14BAG 700CAS JP. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: DRUG DIDN'T COME OUT DURING AIR PURGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    496867 BD PEN NDL 31GA 5MM 14BAG 700CAS JP PEN NEEDLE FMI BECTON DICKINSON AND CO. 8072970

    Patients

    Seq Age Sex Outcome Treatment
    1 Other