BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ LUER-LOK¿ BLUNT FILL NEEDLE

    MDR report key: 7098118 · Received December 7, 2017

    Report

    Report Number
    1213809-2017-00374
    Event Type
    Malfunction
    Date Received
    December 7, 2017
    Date of Event
    November 13, 2017
    Report Date
    March 7, 2018
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    00382903050604
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: SAMPLE EVALUATION: ONE LOOSE 10ML ASSEMBLED SYRINGE WITH 1 ½¿ BLUNT FILL NEEDLE WAS RECEIVED BY BD CANAAN FROM UNKNOWN BATCH #. THE REPORTED MATERIAL # 305060 IS FOR A 3ML SYRINGE WITH 1 ½¿ BLUNT FILL NEEDLE. THE ACTUAL SAMPLE IS A 10ML SYRINGE WITH 1 ½¿ BLUNT FILL NEEDLE. A BATCH # WAS WRITTEN ON A PIECE OF CARDBOARD IN THE SAMPLE BAG. THE BATCH # 7150626 IS FOR A 10ML SYRINGE ONLY/NO NEEDLE PRODUCT, WHICH DID NOT MATCH THE SAMPLE RECEIVED, THEREFORE THE DHR REVIEW WAS NOT PERFORMED. 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. BASED ON THE SAMPLE EVALUATION: CONFIRMED: BD CANAAN WAS ABLE TO CONFIRM THE CUSTOMER'S INDICATED FAILURE. INVESTIGATION CONCLUSION: ROOT CAUSE INVESTIGATION IS NOT POSSIBLE WITHOUT A BATCH AND MATERIAL #. BASED ON THE SEVERITY ASSIGNED TO THIS COMPLAINT AND THE RESULTS OF THE COMPLAINT LOT HISTORY CHECK, CAPA IS NOT REQUIRED AT THIS TIME.

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. (B)(4). DEVICE MANUFACTURE DATE: UNKNOWN. 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 THAT THE BD¿ LUER-LOK¿ BLUNT FILL NEEDLE HAD GOOEY FOREIGN MATTER INSIDE THE SYRINGE WHEN THE NURSE PULLED BACK ON THE PLUNGER. FOUND DURING USE. NO SERIOUS INJURY OR MEDICAL INTERVENTION NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    875227 BD¿ LUER-LOK¿ BLUNT FILL NEEDLE PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS UNKNOWN 00382903050604

    Patients

    Seq Age Sex Outcome Treatment
    1 Other