BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE WITH BD PRECISIONGLIDE¿ NEEDLE

    MDR report key: 8051700 · Received November 8, 2018

    Report

    Report Number
    1213809-2018-00769
    Event Type
    Malfunction
    Date Received
    November 8, 2018
    Date of Event
    October 18, 2018
    Report Date
    December 18, 2018
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903095811
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 0

    ONE PHOTO AND VIDEO WERE RECEIVED AND EVALUATED. THE PHOTO DEPICTED PORTION OF A BOX OR A SHELF CARTON WITH A LABEL ATTACHED SHOWING BATCH #8253730 (P/N 309581) BUT NO PRODUCT. THE VIDEO SHOWED A LOOSE 3ML LL SYRINGE IN A PERSON¿S HAND WITH A STOPPER IN A BOTTOM OUT POSITION. THE PLUNGER WAS BEING SLOWLY PULLED BACK. SILICONE STRINGING COULD BE SEEN FORMING FROM THE ROOF TO THE STOPPER UNTIL THE STOPPER REACHED APPROXIMATELY 0.4 ML AT WHICH POINT THE STRING BROKE AND VISIBLE SMALL POOLING OF SILICONE COULD BE SEEN ON THE STOPPER SURFACE. THE AMOUNT OF SILICONE OBSERVED WAS CLEARLY 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. POTENTIAL ROOT CAUSE FOR THE EXCESSIVE SILICONE DEFECT IS ASSOCIATED WITH THE ASSEMBLY PROCESS. NO CORRECTIVE ACTIONS ARE NECESSARY BASED ON THE DEFECTIVE RATE IDENTIFIED. A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS A "GOOPY CLEAR LIQUID" BETWEEN THE HUB AND PLUNGER OF THE BD SYRINGE WITH BD PRECISIONGLIDE NEEDLE. THERE WAS NO REPORT OF EXPOSURE, 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 THAT THERE WAS A "GOOPY CLEAR LIQUID" BETWEEN THE HUB AND PLUNGER OF THE BD SYRINGE WITH BD PRECISIONGLIDE¿ NEEDLE. THERE WAS NO REPORT OF EXPOSURE, INJURY, OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    893260 BD SYRINGE WITH BD PRECISIONGLIDE¿ NEEDLE PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 8253730 30382903095811

    Patients

    Seq Age Sex Outcome Treatment
    1 Other