BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD CONVENTIONAL NEEDLES

    MDR report key: 20038389 · Received August 22, 2024

    Report

    Report Number
    3002682307-2024-00167
    Event Type
    Malfunction
    Date Received
    August 22, 2024
    Date of Event
    June 14, 2024
    Report Date
    August 20, 2024
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    UDI-DI
    00382903004003
    PMA / PMN Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    E. FACILITY NAME EXCEEDS THE CHARACTER LIMIT: (B)(6). MDR WAS GENERATED DUE TO INVESTIGATION FINDINGS: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 300400 AND LOT NUMBER 220526. 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, TWO (2) PICTURES WERE RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. THE PICTURES SHOWED A SHELF CARTON DISPLAYING MATERIAL 300400 AND LOT 220526 WITH A STRIP OF PRODUCT DISPLAYING MATERIAL 300600 AND LOT 220502. WE UNDERSTAND THAT THE STRIP OF LOT 220502 PRODUCT WAS FOUND INSIDE THE SHELF CARTON AND THEREFORE, AN ISSUE OF PRODUCT MIX-UP TOOK PLACE. DURING THE MANUFACTURING PROCESS, THE PACKAGING MACHINES INTRODUCE THE NEEDLE BLISTERS DIRECTLY INTO THE SHELF CARTON, THERE ARE NO MANUAL PROCESSES PERFORMED DURING THIS STEP. WE HAVE REVIEWED THE BATCHES THAT WERE MANUFACTURED IN THE PACKAGING MACHINE PRIOR TO THE REPORTED PRODUCT AND FOUR (4) CONSECUTIVE BATCHES OF G23X1¿ WERE MANUFACTURED. THEREFORE, WE HAVE DISCARDED A LINE CLEARANCE ISSUE AS A POSSIBLE ROOT CAUSE. THE NEEDLES BELONGING TO LOT 220502 WERE PACKAGED FROM 02-MAY TO 05-MAY 2022 WITH NO QUALITY ISSUES IDENTIFIED. LOT 220526 PRODUCT WAS MANUFACTURED ON DIFFERENT DAYS, FOURTEEN (14) DAYS SEPARATE FROM LOT 220502, WITH DIFFERENT PRODUCT MANUFACTURED ON THE LINE IN BETWEEN. THIS INDICATES THAT THE TWO INVOLVED PRODUCTS DID NOT COEXIST IN THE MANUFACTURING AREA AT ANY TIME. NO REWORKS WERE PERFORMED THAT WOULD IMPLY THE PRODUCT WAS MANIPULATED DURING MANUFACTURE EITHER. BASED ON THE INVESTIGATION RESULTS, A CAUSE FOR THE MIX-UP CANNOT BE IDENTIFIED AT THIS TIME. CONSIDERING THAT THIS IS A REPORTED ISSUE OF MIX-UP, OUR QUALITY TEAM WILL CONTINUE TO CLOSELY MONITOR THE MANUFACTURING PROCESS FOR SIGNS OF THIS POTENTIAL DEFECT AND ANY EMERGING TRENDS AND IDENTIFY IF FURTHER ACTION IS NECESSARY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD CONVENTIONAL NEEDLES SELF BOX CONTAINED A SLEEVE OF A DIFFERENT MATERIAL NUMBER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: BEFORE USE CUSTOMER REQUESTED 300400. HOWEVER WHEN THEY RECEIVED, THE SHELFBOX CONTAINED 300600.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    941358 BD CONVENTIONAL NEEDLES NEEDLES/HYPODERMIC FMI BECTON DICKINSON, S.A. 220526 00382903004003

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown