BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK¿ 3ML SYRINGE LUER-LOK¿

    MDR report key: 7002297 · Received November 5, 2017

    Report

    Report Number
    1213809-2017-00228
    Event Type
    Malfunction
    Date Received
    November 5, 2017
    Date of Event
    October 12, 2017
    Report Date
    October 13, 2017
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096580
    PMA / PMN Number
    K110771
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER PHONE #: (B)(6). RESULTS: INVESTIGATION SUMMARY: DHR REVIEW FOR BATCH #7060629. ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT WITH NO QUALITY NOTIFICATIONS RELATED TO THE COMPLAINT DEFECT. BATCH 7060629 WAS INSPECTED AND ACCEPTED BASED ON MEETING OUR INSPECTION CONTROL PLAN AND SUBSEQUENTLY APPROVED FOR SHIPMENT. SAMPLE EVALUATION TWO PHOTOS DEPICTING THE SAME ONE 5ML SYRINGE SAMPLE WERE RECEIVED BY BD (B)(4) AND EVALUATED. THE SAMPLE WAS IN ITS ORIGINAL SEALED PACKAGING AND CONFIRMED TO BE FROM BATCH #7060629 (309658). BROWN FM SPOTS WERE OBSERVED ON THE LUER COLLAR OF THE SYRINGE. THE FM WAS DESCRIBED AS EMBEDDED. THE EMBEDDED FM IS MOST LIKELY DEGRADED PLASTIC. THIS OCCURS WHEN THE RESIN IS EXPOSED TO PROLONGED HIGH TEMPERATURES INSIDE THE MOLDING MACHINE, SUCH AS DURING START UP. PER PROCEDURE, AFTER START UP, ALL MOLDED PARTS ARE SCRAPPED UNTIL NO DEGRADED PLASTIC IS OBSERVED. IF THIS IS NOT PERFORMED THOROUGHLY A PIECE WITH THIS CONDITION CAN GET THROUGH. THIS TYPE OF DEFECT IS COSMETIC AND DOES NOT POSE RISK TO THE CUSTOMER. BASED ON THE SAMPLE EVALUATION: CONFIRMED: BD (B)(4) WAS ABLE TO CONFIRM THE CUSTOMER'S INDICATED FAILURE. ROOT CAUSE: PROLONGED EXPOSURE OF PLASTIC RESIN TO HEAT. FAILURE TO CONTAIN DEFECT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ¿DIRT¿ WAS FOUND INSIDE A SEALED PACKAGE OF A (B)(4) ¿ 3ML SYRINGE LUER-LOK¿ PRIOR TO USE. THERE WAS NO REPORT OF MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    781638 BD PLASTIPAK¿ 3ML SYRINGE LUER-LOK¿ SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 7060629 30382903096580

    Patients

    Seq Age Sex Outcome Treatment
    1 Other