BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 10506549 · Received September 9, 2020

    Report

    Report Number
    1213809-2020-00608
    Event Type
    Malfunction
    Date Received
    September 9, 2020
    Date of Event
    February 29, 2020
    Report Date
    September 17, 2020
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096269
    PMA / PMN Number
    K980580
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVAL?: YES. D.10. RETURNED TO MANUFACTURER ON: 9/4/2020. H.6. INVESTIGATION: THREE PHOTOS AND ONE 1ML SYRINGE IN AN OPENED BLISTER PACK FROM BATCH 8294987 (P/N 309626) WAS RECEIVED AND EVALUATED. IT WAS OBSERVED THE STOPPER WAS NOT SECURED THE PLUNGER ROD AND CAUGHT BETWEEN THE PLUNGER ROD AND BARREL WALL NEAR THE MIDDLE. THE INSECURE STOPPER CONDITION WAS REJECTABLE PER PRODUCT SPECIFICATION. POTENTIAL ROOT CAUSE FOR THE INSECURE STOPPER DEFECT IS ASSOCIATED WITH THE ASSEMBLY PROCESS. 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 SYRINGE 1ML S/T W/NDL 25X5/8 RB CONTAINED FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT THERE WAS A SOLID FOREIGN SUBSTANCE INSIDE THE BARREL OF THE SYRINGE. PER EMAIL: ON (B)(6) 2020, DURING YELLOW FEVER MANUFACTURING, A FOREIGN SUBSTANCE WAS VISIBLE ON THE INTERIOR OF THE SYRINGE BARREL COMMODITY (B)(6)."

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SYRINGE 1 ML S/T W/ NDL 25 X 5/8 RB CONTAINED FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT THERE WAS A SOLID FOREIGN SUBSTANCE INSIDE THE BARREL OF THE SYRINGE. PER EMAIL: ON (B)(6) 2020, DURING YELLOW FEVER MANUFACTURING, A FOREIGN SUBSTANCE WAS VISIBLE ON THE INTERIOR OF THE SYRINGE BARREL COMMODITY 3112841."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    976783 SYRINGE 1ML S/T W/NDL 25X5/8 RB PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 309626 8294987 30382903096269

    Patients

    Seq Age Sex Outcome Treatment
    1 Other