BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1 ML BD LUER-LOK¿ DISPOSABLE SYRINGE

    MDR report key: 7148934 · Received December 27, 2017

    Report

    Report Number
    1213809-2017-00393
    Event Type
    Malfunction
    Date Received
    December 27, 2017
    Date of Event
    December 5, 2017
    Report Date
    January 19, 2018
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096283
    PMA / PMN Number
    K941562
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DHR REVIEW FOR BATCH 7030533 (P/N 309628): MANUFACTURING DATES: 02/11/2017 TO 02/12/2017. BATCH QUANTITY WAS (B)(4). ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT WITH NO QUALITY NOTIFICATIONS RELATED TO THE COMPLAINT DEFECT. BATCH 7030533 WAS INSPECTED AND ACCEPTED BASED ON MEETING OUR INSPECTION CONTROL PLAN AND SUBSEQUENTLY APPROVED FOR SHIPMENT. TWO PHOTOS WERE RECEIVED BY BD CANAAN AND EVALUATED. A CLOSE-UP OF A 1ML LL SYRINGE FROM A REPORTED BATCH #7030533 (P/N 309628) WAS DEPICTED IN THE PHOTOS. A PIECE OF LARGE BLACK FM COULD BE SEEN ON TOP OF THE STOPPER IN THE FLUID PATH. THE FM APPEARED TO BE A FLAT LONG PIECE OF STOPPER TRIM FROM THE STOPPER MANUFACTURER. IT BECAME INADVERTENTLY ATTACHED TO THE STOPPER LIKELY DURING THE STOPPER WASHING AND SILICONIZATION PROCESS AND LATER ASSEMBLED INTO THE BARREL. BD CANAAN WAS ABLE TO CONFIRM THE CUSTOMER'S INDICATED FAILURE. BASED ON THE SEVERITY ASSIGNED TO THIS COMPLAINT AND THE RESULTS OF THE COMPLAINT LOT HISTORY CHECK, CAPA IS NOT REQUIRED AT THIS TIME. 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.

    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 AND/OR DEVICE HISTORY REVIEW, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOREIGN MATTER (DESCRIBED AS "LOOKS LIKE A PIECE OF RUBBER FROM THE STOPPER¿) WAS FOUND IN A 1 ML BD LUER-LOK¿ DISPOSABLE SYRINGE, AFTER DRAWING UP MEDICATION. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    928793 1 ML BD LUER-LOK¿ DISPOSABLE SYRINGE SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 7030533 30382903096283

    Patients

    Seq Age Sex Outcome Treatment
    1 Other