BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK¿ SYRINGE WITH. BD PRECISIONGLIDE¿ NEEDLE

    MDR report key: 7526043 · Received May 18, 2018

    Report

    Report Number
    1213809-2018-00289
    Event Type
    Malfunction
    Date Received
    May 18, 2018
    Date of Event
    April 30, 2018
    Report Date
    May 23, 2018
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903095750
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: A SINGLE LOOSE ASSEMBLED 3ML SYRINGE WAS RECEIVED, REPORTED TO BE FROM BATCH # 8010879 (P/N 309575). THE SAMPLE WAS VISUALLY EVALUATED. THE SYRINGE WAS FOUND TO HAVE DRIED WHITE FLUID RESIDUE LOCATED AT STOPPER, BETWEEN STOPPER RIBS, AND THROUGHOUT THE PLUNGER ROD. THE PLUNGER ROD WAS LOOSE AND SHORT SHOT OF PLUNGER CROWN WAS OBSERVED. PRODUCT DEFECT OF LEAKAGE COULD BE CONFIRMED BASED ON SAMPLE EVALUATION. DHR REVIEW FOR BATCH # 8010879 (P/N 309575) MANUFACTURING DATA: 01/23/2018 ¿ 01/23/2018. BATCH QUANTITY WAS (B)(4). ASSEMBLY RECORD WAS REVIEWED AS PART OF THIS DHR REVIEW. ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT WITH QUALITY ISSUE REGARDING SHORT SHOT BUT NOT RELATED TO THE COMPLAINT DEFECT. (B)(4) WERE SCRAP AND LEAKAGE TEST WAS PASSED. BATCH 8010879 WAS INSPECTED AND ACCEPTED BASED ON MEETING OUR INSPECTION CONTROL PLAN AND SUBSEQUENTLY APPROVED FOR SHIPMENT. THE REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. POSSIBLE ROOT CAUSE IS THE SHORT SHOT OF PLUNGER CROWN THAT LIKELY RESULTED IN LOOSE STOPPER AND INSUFFICIENT SEAL FORMED LEADING TO LEAKAGE PAST STOPPER. CAPA NOT REQUIRED BASED ON SEVERITY AND OCCURRENCE LEVEL DEFINED FOR THIS COMPLAINT. 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 · 1

    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 · 1

    IT WAS REPORTED THAT BEFORE USE A BD LUER-LOK¿ SYRINGE WITH BD PRECISIONGLIDE¿ NEEDLE WAS FOUND LEAKING " WHILE DRAWING UP VACCINE." IT WAS FOUND TO BE LEAKING PAST THE STOPPER. THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTION NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    368146 BD LUER-LOK¿ SYRINGE WITH. BD PRECISIONGLIDE¿ NEEDLE SYRINGE AND NEEDLE FMF BECTON DICKINSON MEDICAL SYSTEMS 8010879 30382903095750

    Patients

    Seq Age Sex Outcome Treatment
    1 Other