BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTEGRA¿ SYRINGE WITH DETACHABLE NEEDLE

    MDR report key: 8277972 · Received January 25, 2019

    Report

    Report Number
    1213809-2019-00109
    Event Type
    Malfunction
    Date Received
    January 25, 2019
    Date of Event
    December 25, 2018
    Report Date
    April 18, 2019
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    MEG
    UDI-DI
    30382903052722
    PMA / PMN Number
    K011103
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: MEDICAL DEVICE LOT #: 8002923. MEDICAL DEVICE EXPIRATION DATE: 12/31/2022. DEVICE MANUFACTURE DATE: 1/2/2018. INVESTIGATION SUMMARY: TWO 3ML INTEGRA SYRINGES WITH NEEDLES WERE RECEIVED AND VISUALLY INSPECTED. ONE WAS LOOSE AND ONE WAS IN AN OPENED BLISTER PACK FROM BATCH #8002923 (P/N 305272). IT WAS OBSERVED THAT BOTH NEEDLES HAD ENGAGED THE RETRACTION MECHANISM AS THE METAL CUTTER WAS EXPOSED THROUGH THE STOPPER AND THE THUMB REST WAS IN THE CORRECT POSITION JUST ABOVE THE TOP OF THE BARREL. HOWEVER, BOTH SAMPLES HAD BEEN USED AND THE NEEDLE RETRACTION MECHANISM COULD NOT BE EXAMINED DUE TO UNSTERILE CONTAMINATED NEEDLES. THEREFORE, THE DEFECT COULD NOT BE INDEPENDENTLY CONFIRMED. FURTHERMORE, 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 ROOT CAUSE NOT DEFINED SINCE DEFECTS WERE NOT CONFIRMED IN SAMPLES RECEIVED. NO CORRECTIVE ACTIONS RECOMMENDED SINCE PRODUCT DEFECT WAS NOT CONFIRMED.

    Description of Event or Problem · 0

    IT WAS REPORTED WITH THE USE OF THE BD INTEGRA¿ SYRINGE WITH DETACHABLE NEEDLE THERE WAS AN ISSUE WITH LEAKAGE FROM THE SYRINGE AS THE PLUNGER WAS DEPRESSED. WHEN THE PLUNGER WAS DEPRESSED FULLY THE NEEDLE DID NOT RETRACT AND INSTEAD SEPARATED FROM THE SYRINGE REMAINING IN THE PATIENT. NEEDLE WAS MANUALLY REMOVED.

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED WITH THE USE OF THE BD INTEGRA¿ SYRINGE WITH DETACHABLE NEEDLE THERE WAS AN ISSUE WITH LEAKAGE FROM THE SYRINGE AS THE PLUNGER WAS DEPRESSED. WHEN THE PLUNGER WAS DEPRESSED FULLY THE NEEDLE DID NOT RETRACT AND INSTEAD SEPARATED FROM THE SYRINGE REMAINING IN THE PATIENT. NEEDLE WAS MANUALLY REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69880 BD INTEGRA¿ SYRINGE WITH DETACHABLE NEEDLE PISTON SYRINGE MEG BECTON DICKINSON MEDICAL SYSTEMS 8002923 30382903052722

    Patients

    Seq Age Sex Outcome Treatment
    1 Other