BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 1ML S/T W/NDL 25X5/8 RB

    MDR report key: 8672189 · Received June 5, 2019

    Report

    Report Number
    1213809-2019-00592
    Event Type
    Malfunction
    Date Received
    June 5, 2019
    Date of Event
    May 17, 2019
    Report Date
    July 10, 2019
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096269
    PMA / PMN Number
    K980580
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: ONE PHOTO AND THREE 1ML SYRINGES WITH NEEDLES IN FULLY SEALED BLISTER PACKS CONFIRMED TO BE FROM BATCH #9053640 (P/N 309626) WERE RECEIVED AND EVALUATED. IT WAS OBSERVED ALL THE SYRINGES HAD A JAMMED STOPPER CONDITION AND WERE REJECTABLE PER PRODUCT SPECIFICATION. POTENTIAL ROOT CAUSE FOR THE JAMMED STOPPER DEFECT IS ASSOCIATED WITH THE ASSEMBLY PROCESS. IT WAS MOST LIKELY CAUSED BY A MISALIGNMENT BETWEEN THE PLUNGER AND BARREL DIALS. A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT TWO SYRINGE 1ML S/T W/NDL 25X5/8 RB EXPERIENCED A MISALIGNED/JAMMED STOPPER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 309626 BATCH NO.: 9053640 VERBATIM: THE SYRINGES WERE FOUND WITH THE PLUNGER MISPLACED.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TWO SYRINGE 1ML S/T W/NDL 25X5/8 RB EXPERIENCED A MISALIGNED/JAMMED STOPPER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 309626, BATCH NO.: 9053640. VERBATIM: THE SYRINGES WERE FOUND WITH THE PLUNGER MISPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    463539 SYRINGE 1ML S/T W/NDL 25X5/8 RB PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 9053640 30382903096269

    Patients

    Seq Age Sex Outcome Treatment
    1 Other