BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE CONTROL 10ML LL

    MDR report key: 13101679 · Received December 28, 2021

    Report

    Report Number
    1213809-2021-00824
    Event Type
    Malfunction
    Date Received
    December 28, 2021
    Date of Event
    December 1, 2021
    Report Date
    January 28, 2022
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096955
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10: DEVICE AVAILABLE FOR EVAL?: YES. RETURNED TO MANUFACTURER ON: 2022-01-13. H3: DEVICE RETURNED TO MANUFACTURER?: YES. H3: DEVICE EVAL BY MANUFACTURER?: YES. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: D4: MEDICAL DEVICE LOT #: 1238923; D4: MEDICAL DEVICE EXPIRATION DATE: 2026-08-31; H4: DEVICE MANUFACTURE DATE: 2021-08-26. D4: MEDICAL DEVICE LOT #: 1146086; D4: MEDICAL DEVICE EXPIRATION DATE: 2026-05-31; H4: DEVICE MANUFACTURE DATE: 2021-05-26. D4: MEDICAL DEVICE LOT #: 1200209; D4: MEDICAL DEVICE EXPIRATION DATE: 2026-07-31; H4: DEVICE MANUFACTURE DATE: 2021-07-19. H6: INVESTIGATION SUMMARY: THIRTY-ONE 10ML CONTROL SYRINGES SEALED IN BLISTER PACKAGES (P/N 309695) WERE RECEIVED. ONE SAMPLE WAS FROM BATCH #1146086, ONE SAMPLE WAS FROM BATCH #1200209, AND TWENTY-NINE FROM BATCH #1238923. THE SAMPLES WERE FORCE TESTED FOR THUMB GRIP WELD STRENGTH. EACH SAMPLE WAS YIELDED ACCEPTABLE RESULTS PER PRODUCT SPECIFICATION. SINCE THE SAMPLES RECEIVED DID NOT DISPLAY THE REPORTED CONDITION A POTENTIAL ROOT CAUSE COULD NOT BE ESTABLISHED AND CORRECTIVE ACTIONS ARE NOT NECESSARY. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBERS THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 · 0

    IT WAS REPORTED THAT AT LEAST ONE BD SYRINGE CONTROL 10ML LL EXPERIENCED A DAMAGED PLUNGER ROD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE DR. WAS INJECTING LOCAL INTO THE PATIENT AND AS HE WAS DOING SO THE TOP RING OF THE CONTROL SYRINGE SLIDE OFF AND SNAPPED A PART OF THE PLUNGER, RESULTING IN THE SYRINGE SLIPPING AND THE NEEDLE STICKING THE DR. THE NURSE BROUGHT THE SYRINGE TO ME AND EXPLAINED THAT THIS PARTICULAR ISSUE HAS OCCURRED SEVERAL OTHER TIMES IN THE OR, NONE RESULTING IN INJURY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AT LEAST ONE BD SYRINGE CONTROL 10ML LL EXPERIENCED A DAMAGED PLUNGER ROD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE DOCTOR WAS INJECTING LOCAL INTO THE PATIENT AND AS HE WAS DOING SO THE TOP RING OF THE CONTROL SYRINGE SLIDE OFF AND SNAPPED A PART OF THE PLUNGER, RESULTING IN THE SYRINGE SLIPPING AND THE NEEDLE STICKING THE DR. THE NURSE BROUGHT THE SYRINGE TO ME AND EXPLAINED THAT THIS PARTICULAR ISSUE HAS OCCURRED SEVERAL OTHER TIMES IN THE OR, NONE RESULTING IN INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1998430 BD SYRINGE CONTROL 10ML LL PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 309695 SEE H10 30382903096955

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown