BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE LUER-LOK¿ TIP

    MDR report key: 7203962 · Received January 18, 2018

    Report

    Report Number
    1213809-2017-00448
    Event Type
    Malfunction
    Date Received
    January 18, 2018
    Date of Event
    December 28, 2017
    Report Date
    January 19, 2018
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903029953
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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.

    Additional Manufacturer Narrative · 1

    RESULTS: DHR REVIEW FOR BATCH #7212570 (P/N 302995): MANUFACTURING DATES: 08/31/2017 ¿ 09/01/2017. BATCH QUANTITY WAS 504,000. ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT WITH NO QUALITY NOTIFICATIONS RELATED TO THE COMPLAINT DEFECT. SILICONE WEIGHT TESTS WERE PERFORMED AS PER REQUIREMENT DURING THE MANUFACTURE OF THIS BATCH. BATCH 7212570 WAS INSPECTED AND ACCEPTED BASED ON MEETING OUR INSPECTION CONTROL PLAN AND SUBSEQUENTLY APPROVED FOR SHIPMENT. SAMPLE EVALUATION: THREE SEALED 10ML PACKAGED SYRINGES WERE RECEIVED BY BD CANAAN AND CONFIRMED TO BE FROM BATCH #7212570 (P/N 302995). THE SAMPLES WERE VISUALLY EVALUATED. THE SYRINGES WERE FOUND TO HAVE A SMALL AMOUNT OF VISIBLE SILICONE IN THE BARREL ON THE STOPPER. NO STRINGING AND NO POOLING OF SILICONE WAS OBSERVED. THE AMOUNT OBSERVED WAS A NORMAL AND EXPECTED AMOUNT OF SILICONE FOR THIS PRODUCT PER PRODUCT SPECIFICATION. PLEASE NOTE THAT SILICONE IS AN INERT, NON-TOXIC MEDICAL SUBSTANCE USED AS A LUBRICANT FOR DISPOSABLE HYPODERMIC PRODUCTS. IT IS AN INTEGRAL PART OF THE SYRINGE, ENABLING IT TO PERFORM AS REQUIRED IN VARIOUS CLINICAL APPLICATIONS AND DOES NOT PRESENT A SAFETY OR EFFICACY ISSUE NOR DOES IT IMPACT PRODUCT FUNCTION. THE SILICONE APPLICATION PROCESS IS DESIGNED TO PROVIDE AN EVEN DISTRIBUTION OF SILICONE ON THE INTERIOR OF THE SYRINGE BARREL. SILICONE HAS BEEN IN USE IN THIS APPLICATION FOR OVER 20 YEARS. NO REPORTS ARE KNOWN OF ADVERSE CLINICAL EFFECTS ASSOCIATED WITH THESE PRODUCTS AND UNINTENTIONAL DELIVERY OF SILICONE FLUID LUBRICANT. 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: UNCONFIRMED: BD (B)(4) WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER'S INDICATED FAILURE. CONCLUSION: N/A, NO DEFECTS WERE CONFIRMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE BD SYRINGE LUER-LOK¿ TIP HAD FOREIGN MATTER INSIDE THE BARREL. FOUND BEFORE USE. NO SERIOUS INJURY OR MEDICAL INTERVENTION NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46789 BD SYRINGE LUER-LOK¿ TIP SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 7212570 30382903029953

    Patients

    Seq Age Sex Outcome Treatment
    1 Other