BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 10ML LL BNS

    MDR report key: 11339523 · Received February 17, 2021

    Report

    Report Number
    1213809-2021-00087
    Event Type
    Malfunction
    Date Received
    February 17, 2021
    Date of Event
    January 18, 2021
    Report Date
    March 17, 2021
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    PMA / PMN Number
    K980987
    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: D10: DEVICE AVAILABLE FOR EVAL YES. D10: RETURNED TO MANUFACTURER ON:2021-03-17. H6: INVESTIGATION SUMMARY: ONE PHOTO AND ONE LOOSE 10ML SYRINGE WAS RECEIVED AND EVALUATED. IT WAS OBSERVED THE PLUNGER ROD WAS IN THE BOTTOM OUT POSITION AND A PORTION OF THE STOPPER WAS WEDGED BETWEEN THE RETAINING RING AND BARREL WALL. THE JAMMED STOPPER CONDITION WAS REJECTABLE PER PRODUCT SPECIFICATION. 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. POTENTIAL ROOT CAUSE FOR THE JAMMED STOPPER DEFECT IS ASSOCIATED WITH THE ASSEMBLY PROCESS. IT WAS LIKELY THE RESULT OF A SLIGHT MISALIGNMENT DUE A PLUNGER ROD CAUGHT IN THE DIAL. H3 OTHER TEXT: SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SYRINGE 10ML LL BNS PLUNGER LOOKED ABNORMAL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 301029; BATCH NO.: 8130572. IT WAS REPORTED THAT THE PLUNGER LOOKS VISUALLY ABNORMAL. PER RESPONSE EMAIL: YES THE PLUNGER IS DISTORTED IN THE BARREL OF THE SYRINGE. THE SYRINGE WAS NOT USED. PER SCAN: AS PER PIR "IT WAS REPORTED THAT UPON OPENING THE ACCESSORY PACKAGE A POSSIBLE DEFECT WITH THE 10ML PRESSURE SENSOR SYRINGE WAS OBSERVED. A PHOTO IS INCLUDED. IT WAS THEN STATED THAT THE PLUNGER LOOKS 'VISUALLY ABNORMAL'" PER SPEC-MD-2000096 THIS IS A MAJOR DEFECT.

    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 10ML LL BNS PLUNGER LOOKED ABNORMAL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 301029, BATCH NO.: 8130572. IT WAS REPORTED THAT THE PLUNGER LOOKS VISUALLY ABNORMAL. PER RESPONSE EMAIL: YES THE PLUNGER IS DISTORTED IN THE BARREL OF THE SYRINGE. THE SYRINGE WAS NOT USED. PER SCAN: AS PER PIR "IT WAS REPORTED THAT UPON OPENING THE ACCESSORY PACKAGE A POSSIBLE DEFECT WITH THE 10ML PRESSURE SENSOR SYRINGE WAS OBSERVED. A PHOTO IS INCLUDED. IT WAS THEN STATED THAT THE PLUNGER LOOKS 'VISUALLY ABNORMAL'" PER SPEC-(B)(4) THIS IS A MAJOR DEFECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    233095 SYRINGE 10ML LL BNS PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 8130572

    Patients

    Seq Age Sex Outcome Treatment
    1