BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 1ML LS 25G 5/8IN

    MDR report key: 19301645 · Received May 13, 2024

    Report

    Report Number
    2243072-2024-00621
    Event Type
    Malfunction
    Date Received
    May 13, 2024
    Date of Event
    April 17, 2024
    Report Date
    May 28, 2024
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    PMA / PMN Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    OUR QUALITY ENGINEER INSPECTED THE 3 PHOTOS AND 171 SAMPLE SUBMITTED FOR EVALUATION. THE REPORTED ISSUE OF FOREIGN MATTER WAS CONFIRMED UPON INSPECTION OF THE SAMPLES. ANALYSIS OF THE SAMPLES SHOWED 2 SAMPLES WITH EPOXY TRAILING MORE THAN 4 MM. A REVIEW OF OUR RISK MANAGEMENT DOCUMENTATION WAS PERFORMED AND INDICATES THAT THE POTENTIAL RISK OF THE REPORTED EVENT WAS ASSESSED APPROPRIATELY. PRODUCTION RECORDS WERE REVIEWED, AND THIS BATCH MEETS OUR MANUFACTURING SPECIFICATION REQUIREMENTS. THE NEEDLE ASSEMBLY PROCESS WAS REVIEWED. THE EPOXY TRAILING ABOVE 4MM COULD HAVE BEEN DUE TO THE EPOXY NOZZLE POSITION WAS AWAY FROM THE HIGHEST POINT OF THE HUB. THIS COULD BE DUE TO THE VARIATION OF THE SEATING POSITION OF THE HUB ON THE GREEN RACK PIN. THE NOZZLE POSITION IS ADJUSTED BY THE PRODUCTION TECHNICIAN DURING CHANGEOVER, HENCE THERE IS A POSSIBILITY THAT THE ALIGNMENT WAS INADEQUATELY PERFORMED. THERE WERE ALSO NO APPROPRIATE TOOLS AND WORK INSTRUCTIONS TO GUIDE THE PRODUCTION TECHNICIAN ON THE EPOXY NOZZLE POSITION ADJUSTMENT. THERE WERE NO SIMILAR COMPLAINTS REPORTED ON THE NONCONFORMANCE FOR THE REPORTED LOTS. CURRENT CONTROLS INCLUDE AN OUTGOING INSPECTION AND IN-PROCESS INSPECTION IN PLACE TO CHECK FOR EPOXY TRAILING AT THE NEEDLE ASSEMBLY PROCESS. CORRECTIVE ACTIONS WILL BE COMPLETED TO PREVENT THIS DEFECT IN THE FUTURE. THIS INCLUDES REVISING THE PROCESS CHECKLIST TO ADD A VERIFICATION OF A 0.5MM GAP BETWEEN THE EPOXY NOZZLE AND THE HIGHEST POINT OF THE HUB USING FILLER GAUGE. A REVISION OF THE WORK INSTRUCTION WILL ALSO BE COMPLETED TO ADD INSTRUCTIONS FOR EPOXY NOZZLE ADJUSTMENT AND TO TRAIN ALL ASSEMBLY LINE PRODUCTION TECHNICIANS ON THE UPDATED PROCEDURE. AFTER THE PROCESS CHECKLIST AND PROCEDURE HAVE BEEN REVISED, 4 RANDOM AUDITS AT DIFFERENT DAYS AT THE ASSEMBLY LINE WILL BE PERFORMED TO VERIFY THAT THE GAP BETWEEN THE EPOXY NOZZLE AND HIGHEST POINT OF HUB IS 0.5MM.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD SYRINGE 1ML LS 25G 5/8IN HAD FOREIGN MATTER CUSTOMERS FOUND THE WHILE PAINT ATTACHED TO THE NEEDLE AND THE SIMILAR CONDITION HAS BEEN OBSERVED FROM THE BATCHES, INCLUDING 2106880, 0052770, 2112896, AND 2174203 .

    Description of Event or Problem · 0

    CUSTOMERS FOUND THE WHILE PAINT ATTACHED TO THE NEEDLE AND THE SIMILAR CONDITION HAS BEEN OBSERVED FROM THE BATCHES, INCLUDING 2106880, 0052770, 2112896, AND 2174203 .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    456780 BD SYRINGE 1ML LS 25G 5/8IN SYRINGE FMF BECTON DICKINSON 2174203

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown