BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA-FINE¿ 4MM PEN NEEDLES

    MDR report key: 13423572 · Received February 2, 2022

    Report

    Report Number
    9616656-2022-00078
    Event Type
    Malfunction
    Date Received
    February 2, 2022
    Date of Event
    January 17, 2022
    Report Date
    March 10, 2022
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL REPORTER ADDRESS: (B)(6). A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY TWO PHOTOS OF TWO 32G X 4MM PEN NEEDLES WERE RETURNED, ONE FROM LOT. NO. 1012823 AND THE OTHER FROM LOT. NO. 1118185. VISUAL EXAMINATION OF THE RETURNED PHOTOS WAS CARRIED OUT A DAMAGED COVER WAS OBSERVED ON THE PEN NEEDLE FROM LOT. NO. 1118185 AND A BURN MARK ON THE COVER WAS OBSERVED ON THE PEN NEEDLE FROM LOT. NO. 1012823. A LOT HISTORY REVIEW WAS CARRIED OUT AND NO RELATED NON CONFORMANCES WERE RAISED IN ASSOCIATION WITH THESE PACKAGED LOTS CONCLUDING ALL INSPECTIONS WERE PERFORMED AS PER THE APPLICABLE OPERATIONS AND MET QC SPECIFICATIONS. THE MOST LIKELY CAUSE OF THE DAMAGED COVER OCCURRED AT THE PICK AND PLACE STATION DURING ASSEMBLY. THE ROOT CAUSE OF THE MARK ON THE COVER IS DEGRADED COVER MATERIAL WHICH OCCURRED UPON MACHINE STARTUP AND AFTER THE INTRODUCTION OF HEAT WHICH IS A NORMAL PART OF THE MOULDING PROCESS.

    Additional Manufacturer Narrative · 0

    INITIAL REPORTER ADDRESS: (B)(6). 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 · 0

    IT WAS REPORTED WHILE USING BD ULTRA-FINE¿ 4MM PEN NEEDLES THE STERILITY WAS COMPROMISED ON ONE PIECE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: LOT 1118185 : 1 PC FOUND DAMAGED DURING REPACKING.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD ULTRA-FINE¿ 4MM PEN NEEDLES THE STERILITY WAS COMPROMISED ON ONE PIECE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: LOT 1118185 : 1 PC FOUND DAMAGED DURING REPACKING.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD ULTRA-FINE¿ 4MM PEN NEEDLES THE STERILITY WAS COMPROMISED ON ONE PIECE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: LOT 1118185 : 1 PC FOUND DAMAGED DURING REPACKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    72781 BD ULTRA-FINE¿ 4MM PEN NEEDLES HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 1118185

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown