BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5 ML BD LUER-LOK¿ SYRINGE

    MDR report key: 6824387 · Received August 28, 2017

    Report

    Report Number
    1213809-2017-00109
    Event Type
    Malfunction
    Date Received
    August 28, 2017
    Date of Event
    August 2, 2017
    Report Date
    December 5, 2017
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    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. (B)(4).

    Additional Manufacturer Narrative · 1

    ONE LOOSE 5ML ASSEMBLED SYRINGE WAS RECEIVED BY BD CANAAN AND REPORTED TO BE FROM BATCH #7001794 (P/N 309703). THE SAMPLE WAS VISUALLY EVALUATED. THE SYRINGE WAS FOUND TO HAVE A BLACK SPOT LOCATED AT THE BARREL LUER. THE SAMPLE WAS REVIEWED WITH A MOLDING PROCESS ENGINEER. THE FM WAS DETERMINED TO BE EMBEDDED AND WAS IDENTIFIED AS OVER PROCESSED OR BURNT PLASTIC. THIS TYPE OF DEFECT IS COSMETIC AND DOES NOT POSE RISK TO THE CUSTOMER. HOWEVER, THE EFM IS LEVEL 3 IN SIZE, WHICH IS A REJECTABLE CONDITION AT BD CANAAN. COMPLAINTS RECEIVED FOR THIS PRODUCT AND CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. BASED ON THE SAMPLE EVALUATION: CONFIRMED: BD CANAAN WAS ABLE TO CONFIRM THE CUSTOMER'S INDICATED FAILURE EXTENDED EXPOSURE TO HEAT DURING MOLDING PRESS START UP. DHR REVIEW FOR BATCH #7001794 (P/N 309703): MANUFACTURING DATES: 2/08/17 ¿ 2/09/17. ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT WITH NO QUALITY NOTIFICATIONS RELATED TO THE COMPLAINT DEFECT. BATCH 7001794 WAS INSPECTED AND ACCEPTED BASED ON MEETING OUR INSPECTION CONTROL PLAN AND SUBSEQUENTLY APPROVED FOR SHIPMENT. DHR REVIEW FOR BATCH #7001796 (P/N 309703). MANUFACTURING DATES: 1/07/17 ¿ 1/08/17. ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT WITH NO QUALITY NOTIFICATIONS RELATED TO THE COMPLAINT DEFECT. BATCH 7001796 WAS INSPECTED AND ACCEPTED BASED ON MEETING OUR INSPECTION CONTROL PLAN AND SUBSEQUENTLY APPROVED FOR SHIPMENT. THREE PHOTOS WERE RECEIVED BY BD CANAAN DEPICTING SAMPLES FROM EITHER BATCH #7001794 OR #7001796 (P/N 309703). THEY WERE EVALUATED FOR THE REPORTED DEFECTS. IN ONE OF THE SAMPLES, A PIECE OF RUBBER CAN BE SEEN HANGING FROM THE STOPPER. FM SPOTS WERE OBSERVED ON THE BARREL OF 3 OTHER SAMPLES. HOWEVER, THE PHOTOS WERE OF LOW RESOLUTION, SO IT WAS NOT POSSIBLE TO EVALUATE THE FM IN DETAIL TO IDENTIFY IT. COMPLAINTS RECEIVED FOR THIS PRODUCT AND CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A BLACK DOT WAS EMBEDDED ON THE LUER-LOK OF THE BD PLASTIPAK¿ 5 ML SYRINGE. THIS WAS OBSERVED BEFORE USE AND THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    605614 5 ML BD LUER-LOK¿ SYRINGE SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 700194

    Patients

    Seq Age Sex Outcome Treatment
    1 Other