BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK¿ SYRINGE

    MDR report key: 7810705 · Received August 23, 2018

    Report

    Report Number
    9610847-2018-00273
    Event Type
    Malfunction
    Date Received
    August 23, 2018
    Date of Event
    June 18, 2018
    Report Date
    September 12, 2018
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FMF
    UDI-DI
    30382903096801
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DUE TO AN IT ISSUE BEGINNING ON (B)(6) 2018, PREVIOUSLY FILED EMDRS DID NOT CONTAIN REQUIRED FIELDS. THIS SUPPLEMENTAL EMDR IS FILED TO PROVIDE THE FOLLOWING OMITTED FIELDS: EVENT ATTRIBUTED TO: OTHER. DEVICE SINGLE USE?: NO. DEVICE RETURNED TO MANUFACTURE: NO. NO PHOTOS OR SAMPLES WERE PROVIDED FOR EVALUATION THEREFORE FAILURE MODE COULD NOT BE VERIFIED. ROOT CAUSE COULD NOT BE DETERMINED. 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. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED. BATCHES 7153612 AND 7153649 OF MATERIAL 8000952 WERE USED TO CREATE THIS BATCH. 7153612: NO RELATED DEFECTS OR QNS WERE RECORDED IN THE DHR. ALL SILICONE WEIGHT TESTING PERFORMED DURING THIS BATCH WAS ACCEPTED AND WITHIN SPECIFICATION. 7242749: NO RELATED DEFECTS OR QNS WERE RECORDED IN THE DHR. ALL SILICONE WEIGHT TESTING PERFORMED DURING THIS BATCH WAS ACCEPTED AND WITHIN SPECIFICATION.

    Description of Event or Problem · 0

    IT WAS REPORTED WITH THE USE OF THE BD LUER-LOK SYRINGE THERE WAS AN ISSUE WITH FOREIGN MATTER. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED WITH THE USE OF THE BD LUER-LOK¿ SYRINGE THERE WAS AN ISSUE WITH FOREIGN MATTER. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    652751 BD LUER-LOK¿ SYRINGE SYRINGE FMF BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 7242749 30382903096801

    Patients

    Seq Age Sex Outcome Treatment
    1 Other