BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEN NDL 31GA 8MM 100 BX 1200 LA

    MDR report key: 10738014 · Received October 26, 2020

    Report

    Report Number
    9616656-2020-01064
    Event Type
    Malfunction
    Date Received
    October 26, 2020
    Date of Event
    October 4, 2020
    Report Date
    December 9, 2020
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    CUSTOMER RETURNED PHOTOS OF 8MM, 31G PEN NEEDLES WITH THE SHELF CARTON FROM LOT # 9183079. CUSTOMER STATES THAT THE NEEDLE PENETRATED INTO ITS OWN PROTECTION SHIELD WITHOUT BEING ABLE TO BE REMOVED. THE PHOTOS WERE EXAMINED AND EXHIBITED THE PATIENT END OF THE CANNULA THROUGH THE INNER SHIELD. 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. BD WAS ABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE. ROOT CAUSE OF THIS ISSUE WAS INCORRECT LOADING OF THE SHIELD TO THE HUB AT THE SHIELDING STATION. SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PEN NDL 31GA 8MM 100 BX 1200 LA EXPERIENCED PRODUCT DAMAGE WHILE STILL CONSIDERED OPERABLE. PRODUCT DEFECT WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: YESTERDAY (10/04) ONE APPEARED, WHICH COULD BE CONSIDERED AN EXTREME CASE, THAT IS, THE NEEDLE PENETRATED INTO ITS OWN PROTECTION SHIELD WITHOUT BEING ABLE TO BE REMOVED. MATERIAL NOT USED BY CUSTOMER. CUSTOMER COMMENTS IN THE E-MAIL: "BENT" NEEDLES NO LONGER APPEARED AFTER MY COMPLAINT.

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER PHONE #: (B)(6). 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 31GA 8MM 100 BX 1200 LA EXPERIENCED PRODUCT DAMAGE WHILE STILL CONSIDERED OPERABLE. PRODUCT DEFECT WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: YESTERDAY (10/04) ONE APPEARED, WHICH COULD BE CONSIDERED AN EXTREME CASE, THAT IS, THE NEEDLE PENETRATED INTO ITS OWN PROTECTION SHIELD WITHOUT BEING ABLE TO BE REMOVED. MATERIAL NOT USED BY CUSTOMER. CUSTOMER COMMENTS IN THE E-MAIL: "BENT" NEEDLES NO LONGER APPEARED AFTER MY COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1203085 PEN NDL 31GA 8MM 100 BX 1200 LA PEN NEEDLE FMI BECTON DICKINSON AND CO. 9183079

    Patients

    Seq Age Sex Outcome Treatment
    1