BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ SYRINGE WITH BD LUER-LOK¿ TIP

    MDR report key: 7173052 · Received January 8, 2018

    Report

    Report Number
    1911916-2017-00391
    Event Type
    Malfunction
    Date Received
    January 8, 2018
    Date of Event
    December 14, 2017
    Report Date
    March 1, 2018
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMF
    UDI-DI
    30382903096535
    PMA / PMN Number
    K110771
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    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, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: NO RELATED ISSUES OR DEFECTS WERE FOUND IN DHR. NO RELATED QUALITY NOTIFICATIONS WERE ISSUED FOR THIS BATCH. A SAMPLE WAS RECEIVED IN THE (B)(4) PLANT FOR EVALUATION. THE SAMPLE HAD SILICONE ON IT THEREFORE FAILURE MODE WAS VERIFIED; HOWEVER IT WAS MINIMAL AND STILL IN THE ACCEPTABLE RANGE. SILICONE TESTING FOR BATCH 7180616: SILICONE WEIGHT SPEC: .0055 - .0120 GRAMS. MIDDLE OF BATCH SILICONE TEST: .095, .095, .0101 .097, .099, .0100. END OF BATCH SILICONE TEST: .095, .096, .099, .0103, .0101, .0102. 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, HOWEVER, SOME SILICONE MAY NOT BE PERFECTLY DISTRIBUTED. SILICONE HAS BEEN IN USE IN THIS APPLICATION FOR OVER 20 YEARS, WITH ESTIMATED DISTRIBUTION WELL IN EXCESS OF (B)(4) UNITS. NO REPORTS ARE KNOWN OF ADVERSE CLINICAL EFFECTS ASSOCIATED WITH THESE PRODUCTS AND UNINTENTIONAL DELIVERY OF SILICONE FLUID LUBRICANT. INVESTIGATION CONCLUSION: THE SAMPLE HAD SILICONE ON IT THEREFORE FAILURE MODE WAS VERIFIED; HOWEVER IT WAS MINIMAL AND STILL IN THE ACCEPTABLE RANGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOREIGN MATTER WAS FOUND IN A BD¿ SYRINGE WITH BD LUER-LOK¿ TIP BEFORE USE. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    17612 BD¿ SYRINGE WITH BD LUER-LOK¿ TIP SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL 7180616 30382903096535

    Patients

    Seq Age Sex Outcome Treatment
    1 Other