BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 10ML LUER-LOK¿ TIP

    MDR report key: 6931370 · Received October 9, 2017

    Report

    Report Number
    1213809-2017-00177
    Event Type
    Malfunction
    Date Received
    October 9, 2017
    Date of Event
    September 15, 2017
    Report Date
    January 8, 2018
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    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. (B)(4).

    Additional Manufacturer Narrative · 1

    A DHR REVIEW FOR BATCH 7201706 WAS PERFORMED, WITH NO QUALITY NOTIFICATIONS RELATED TO THE COMPLAINT DEFECT. ALL SILICONE TESTING WAS PERFORMED AS PER REQUIREMENT WITH NO ISSUES NOTED. BATCH 7201706 WAS INSPECTED AND ACCEPTED BASED ON MEETING OUR INSPECTION CONTROL PLAN AND SUBSEQUENTLY APPROVED FOR SHIPMENT. A TOTAL OF 7 SAMPLES WERE RECEIVED BY BD (B)(4) AND CONFIRMED TO BE FROM BATCH #7201706. VISUAL EVALUATION REVEALED NORMAL SILICONE CONTENT IN 6 OUT OF 7 SAMPLES. EXCESS SILICONE WAS OBSERVED IN ONE OF THE SAMPLES  STRINGING AND POOLING OF SILICONE WAS PRESENT. PLEASE NOTE THAT SILICONE IS AN INERT, NONTOXIC MEDICAL SUBSTANCE USED AS A LUBRICANT FOR DISPOSABLE HYPODERMIC PRODUCTS. NO REPORTS ARE KNOWN OF ADVERSE CLINICAL EFFECTS ASSOCIATED WITH THESE PRODUCTS AND UNINTENTIONAL DELIVERY OF SILICONE FLUID LUBRICANT. CONCLUSION: BASED ON THE SAMPLE, THE INVESTIGATION CONCLUDED BD WAS ABLE TO CONFIRM THE CUSTOMERS INDICATED FAILURE. BASED ON AN EVALUATION OF SEVERITY AND FREQUENCY, IT WAS DETERMINED THAT NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME.

    Additional Manufacturer Narrative · 1

    INCORRECT AWARENESS DATE ENTERED ON INITIAL MDR. CORRECTION DATE OF 09/18/2017 HAS BEEN MADE.

    Description of Event or Problem · 1

    THIS COMPLAINT IS MDR REPORTABLE. IT WAS REPORTED THAT FOREIGN MATTER WAS FOUND IN A BD SYRINGE 10ML LUER-LOK" TIP. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    707938 BD SYRINGE 10ML LUER-LOK¿ TIP SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 7201706

    Patients

    Seq Age Sex Outcome Treatment
    1 Other