BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK¿ DISPOSABLE SYRINGE

    MDR report key: 7342161 · Received March 15, 2018

    Report

    Report Number
    1213809-2018-00114
    Event Type
    Malfunction
    Date Received
    March 15, 2018
    Date of Event
    January 17, 2018
    Report Date
    April 4, 2018
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096283
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: ONE 1ML LUER LOK SYRINGE WITH NO PACKAGING WAS RECEIVED BY BD CANAAN FOR INVESTIGATION. CUSTOMER REPORTED LOT NUMBER #7030526, CATALOG # 309628. BASED ON VISUAL EXAMINATION OF THE RETURNED SAMPLE, STOPPER APPEARED DEFORMED. LEAKAGE IS MOST LIKELY TO HAPPEN AS A RESULT OF THE DEFORMED / DAMAGED STOPPER. LEAKAGE WAS OBSERVED DURING DRAWING AND EXPELLING. PRODUCT DEFECT CONFIRMED BASED ON SAMPLE EVALUATION PERFORMED. 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 TREND DHR REVIEW FOR BATCH 7030526 (P/N 309628): MANUFACTURING DATES: 1/29/2017 TO 2/06/2017 BATCH QUANTITY WAS (B)(4). ASSEMBLY RECORDS WERE REVIEWED AS PART OF THIS DHR REVIEW. ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT WITH NO QUALITY NOTIFICATIONS RELATED TO THE COMPLAINT DEFECT. BATCH 7030526 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. BD WAS ABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE. BASED ON THE SEVERITY AND OCCURRENCE A ROOT CAUSE IS NOT NECESSARY, NOR IS A CAPA.

    Additional Manufacturer Narrative · 1

    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 DURING USE A BD LUER-LOK¿ DISPOSABLE SYRINGE WAS FOUND LEAKING AS A ¿NURSE FOUND SOLUTION LEAKED FROM THE PLUNGER STOPPER WHEN WITHDRAWING SOLUTION.¿ THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185062 BD LUER-LOK¿ DISPOSABLE SYRINGE HYPODERMIC SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 7030526 30382903096283

    Patients

    Seq Age Sex Outcome Treatment
    1 Other