BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 10CC S/T WOS STERILE WATER BNS

    MDR report key: 11311496 · Received February 10, 2021

    Report

    Report Number
    1213809-2021-00067
    Event Type
    Malfunction
    Date Received
    February 10, 2021
    Date of Event
    December 11, 2020
    Report Date
    February 16, 2021
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    PMA / PMN Number
    K980987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY TWO PHOTOS OF A LOOSE 10ML STERILE WATER SYRINGE WERE RECEIVED AND EVALUATED. IT WAS OBSERVED THE PLUNGER ROD WAS IN THE BOTTOMED-OUT POSITION AND A PORTION THE STOPPER WAS WEDGED BETWEEN THE PLUNGER ROD AND BARREL WALL. THE JAMMED STOPPER CONDITION WAS REJECTABLE PER PRODUCT SPECIFICATION. POTENTIAL ROOT CAUSE FOR THE JAMMED 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 10CC S/T WOS STERILE WATER BNS STOPPER WAS DEFORMED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 304086, BATCH NO: 9170732. IT WAS REPORTED THAT THE GASKET OF THE SYRINGE WAS DEFORMED.

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: NA. 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 10CC S/T WOS STERILE WATER BNS STOPPER WAS DEFORMED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 304086, BATCH NO: 9170732. IT WAS REPORTED THAT THE GASKET OF THE SYRINGE WAS DEFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    207979 SYRINGE 10CC S/T WOS STERILE WATER BNS PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 9170732

    Patients

    Seq Age Sex Outcome Treatment
    1