BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE LUER-LOK¿ TIP

    MDR report key: 7089567 · Received December 6, 2017

    Report

    Report Number
    1213809-2017-00373
    Event Type
    Malfunction
    Date Received
    December 6, 2017
    Date of Event
    November 13, 2017
    Report Date
    June 1, 2018
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    00382903029952
    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

    INVESTIGATION SUMMARY: ONE LOOSE 10ML ASSEMBLED SYRINGE WITH 1 ½¿ BLUNT FILL NEEDLE WAS RECEIVED BY BD CANAAN FROM UNKNOWN BATCH #. THE BATCH # 7150626 IS FOR A 10ML SYRINGE ONLY/NO NEEDLE PRODUCT, WHICH DID NOT MATCH THE SAMPLE RECEIVED. THE SAMPLE WAS VISUALLY EVALUATED. THE OILY SUBSTANCE OBSERVED ON THE BLACK STOPPER IS SILICONE USED IN THE MANUFACTURING PROCESS. VISIBLE STRINGING AND POOLING OF SILICONE WAS OBSERVED IN THE SYRINGE ABOVE THE STOPPER. SILICONE CONTENT IN THE SAMPLE PROVIDED WAS EXCESSIVE 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. DHR REVIEW FOR BATCH 7150626 (P/N 302995): MANUFACTURING DATES: 06/15/2017 TO 06/16/2017. BATCH QUANTITY WAS 504,000. ASSEMBLY RECORDS WERE REVIEWED AS PART OF THIS DHR REVIEW. ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT WITH NO QUALITY NOTIFICATIONS RELATED TO THE COMPLAINT DEFECT. SILICONE WEIGHT TESTING WAS PERFORMED AS PER REQUIREMENT WITH ALL TEST RESULTS WITHIN ACCEPTABLE RANGE PER PRODUCT SPECIFICATION. BATCH 7150626 WAS INSPECTED AND ACCEPTED BASED ON MEETING OUR INSPECTION CONTROL PLAN AND SUBSEQUENTLY APPROVED FOR SHIPMENT. INVESTIGATION CONCLUSION: ROOT CAUSE IS UNDETERMINED.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING USE OF THE BD 10 ML SYRINGE LUER-LOK¿ TIP THERE WAS A FOREIGN SUBSTANCE IN THE SYRINGE. NURSE WENT TO DRAW THE MEDICATION, WHEN SHE PULLED BACK ON THE PLUNGER SHE NOTICED A GOOEY SUBSTANCE IN THE SYRINGE. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    865326 BD SYRINGE LUER-LOK¿ TIP SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 7150626 00382903029952

    Patients

    Seq Age Sex Outcome Treatment
    1 Other