BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 1ML LS 200 S/C

    MDR report key: 8758916 · Received July 3, 2019

    Report

    Report Number
    1213809-2019-00697
    Event Type
    Malfunction
    Date Received
    July 3, 2019
    Date of Event
    June 19, 2019
    Report Date
    August 1, 2019
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096597
    PMA / PMN Number
    K980580
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: FOUR PHOTOS AND ONE 1ML SYRINGE IN A FULLY SEALED BLISTER PACK CONFIRMED TO BE FORM BATCH 9081868 (P/N 309659) WERE RECEIVED AND EVALUATED. IT WAS OBSERVED THE STOPPER WAS JAMMED BETWEEN THE PLUNGER ROD AND THE BARREL IN THE MIDDLE OF THE SYRINGE AND IS REJECTABLE PER PRODUCT SPECIFICATION. MACHINE LOGS INDICATE ADJUSTMENTS WERE MADE TO THE ASSEMBLY MACHINE DURING THE MANUFACTURE OF THIS BATCH. ADJUSTMENTS WERE MADE TO THE COMPONENT DIRECTLY INVOLVED WITH THE PLUNGER ROD AND BARREL ASSEMBLY SINCE THE MANUFACTURE OF THIS BATCH. POTENTIAL ROOT CAUSE FOR THE JAMMED STOPPER DEFECT IS ASSOCIATED WITH THE ASSEMBLY PROCESS. THIS IS MOST LIKELY CAUSED BY A MISALIGNMENT BETWEEN THE PLUNGER ROD 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 PRIOR TO USE FOREIGN MATTER WAS DISCOVERED IN THE BARREL WITH A BD SYRINGE 1ML LS 200 S/C. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THAT A BLACK FOREIGN SUBSTANCE WAS FOUND ADHERED WITH THE BARREL OF THE SYRINGE.

    Additional Manufacturer Narrative · 1

    A SAMPLE IS AVAILABLE FOR EVALUATION. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO USE FOREIGN MATTER WAS DISCOVERED IN THE BARREL WITH A BD SYRINGE 1ML LS 200 S/C. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT A BLACK FOREIGN SUBSTANCE WAS FOUND ADHERED WITH THE BARREL OF THE SYRINGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    555210 BD SYRINGE 1ML LS 200 S/C PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 9081868 30382903096597

    Patients

    Seq Age Sex Outcome Treatment
    1 Other