BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MICROLANCE NEEDLE

    MDR report key: 18525160 · Received January 17, 2024

    Report

    Report Number
    3002682307-2024-00003
    Event Type
    Malfunction
    Date Received
    January 17, 2024
    Date of Event
    October 16, 2023
    Report Date
    February 8, 2024
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    UDI-DI
    00382903040001
    PMA / PMN Number
    UKN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 304000 AND LOT NUMBER 220904. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. TO AID IN THE INVESTIGATION OF THIS ISSUE, (B)(4)UNITS OF MATERIAL 301300/LOT 220816 AND A SHELF CARTON FOR MATERIAL 304000 WERE RETURNED FOR EVALUATION BY OUR QUALITY TEAM. NO NEEDLES BELONGING TO MATERIAL 304000 WERE PROVIDED. DURING THE MANUFACTURING PROCESS, THE PACKAGING MACHINE INTRODUCES THE NEEDLE BLISTER PACKAGES DIRECTLY INTO THE SHELF CARTON; NO MANUAL PROCESS IS INVOLVED. MATERIAL 301300/LOT 220816 WAS PACKAGED ON MACHINE 2103 FROM AUGUST 17-19TH 2022 WITH NO QUALITY NOTIFICATIONS (QN) IDENTIFIED. MATERIAL 304000/LOT 220904 WAS PACKAGED ON MACHINE 2101 FROM SEPTEMBER 1-4TH 2022. THE PRODUCTS INVOLVED IN THIS REPORT WERE PACKAGED ON DIFFERENT MACHINES ELEVEN DAYS APART. THERE WERE NO QNS FOUND FOR EITHER LOT TO INDICATE THAT ANY MANIPULATION WAS DONE DURING THE PROCESS THAT COULD HAVE RESULTED IN THIS ISSUE. BASED ON THE INVESTIGATION RESULTS, WE ARE UNABLE TO IDENTIFY AN EXACT MANUFACTURING CAUSE FOR THIS INCIDENT. OUR QUALITY TEAM WILL CONTINUE TO CLOSELY MONITOR THE MANUFACTURING PROCESS FOR SIGNS OF THIS POTENTIAL DEFECT AND ANY EMERGING TRENDS.

    Additional Manufacturer Narrative · 0

    H.3. 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

    NO ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD MICROLANCE NEEDLE POUCHES CONTAIN A DIFFERENT SYRINGE SIZE THAN LABELED ON SHELF BOX. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SHORT DESCRIPTION WRONG PRODUCTS IN THE PACKAGE, PLEASE SEE ATTACHED PICTURES WHEN DID THE INCIDENT OCCUR? BEFORE USE WRONG PRODUCTS IN THE PACKAGE, IT CONTAINS BD MICROLANCE 20G AND IT SHOULD BE 30G.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1774365 BD MICROLANCE NEEDLE NEEDLE, HYPODERMIC FMI BECTON DICKINSON, S.A. 220904 00382903040001

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown