BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTEGRA SYRINGE WITH DETACHABLE NEEDLE

    MDR report key: 9707606 · Received February 13, 2020

    Report

    Report Number
    1213809-2020-00093
    Event Type
    Malfunction
    Date Received
    February 13, 2020
    Date of Event
    January 24, 2020
    Report Date
    April 3, 2020
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    MEG
    UDI-DI
    30382903052708
    PMA / PMN Number
    K011103
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: AN OPENED SHELF CARTON WAS RECEIVED, CONTAINING 109 SEALED PACKAGED INTEGRA SYRINGES, CONFIRMED TO BE FROM BATCH#: 9251667 (P/N: 305270). THE SAMPLES WERE ALL OPENED AND VISUALLY EVALUATED. WHEN MOVING THE STOPPER, A THIN RING MAY BE OBSERVED ON THE BARREL SURFACE AFTER BREAKOUT. THIS IS MEDICAL GRADE SILICONE USED TO LUBRICATE THE STOPPER AND INNER BARREL SURFACE. NO EXCESS SILICONE WAS FOUND IN ANY SYRINGES. ALL SYRINGES CONTAINED NORMAL AND EXPECTED AMOUNT OF SILICONE FOR THIS PRODUCT PER PRODUCT SPECIFICATION. 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. FURTHERMORE, 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 A FOREIGN RING OF CLEAR RESIDUE WAS FOUND INSIDE THE BD INTEGRA¿ SYRINGE WITH DETACHABLE NEEDLE AROUND THE STOPPER BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CONTACT CALLED STATING SHE NOTICED A CLEAR RING ALMOST LIKE A RESIDUE INSIDE THE SYRINGE AROUND THE STOPPER WHEN SHE COMPRESSED THE PLUNGER BEFORE TRYING TO DRAW UP MEDICATION. DISCOVERED BEFORE USE."

    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 A FOREIGN RING OF CLEAR RESIDUE WAS FOUND INSIDE THE BD INTEGRA¿ SYRINGE WITH DETACHABLE NEEDLE AROUND THE STOPPER BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CONTACT CALLED STATING SHE NOTICED A CLEAR RING ALMOST LIKE A RESIDUE INSIDE THE SYRINGE AROUND THE STOPPER WHEN SHE COMPRESSED THE PLUNGER BEFORE TRYING TO DRAW UP MEDICATION. DISCOVERED BEFORE USE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173157 BD INTEGRA SYRINGE WITH DETACHABLE NEEDLE PISTON SYRINGE MEG BECTON DICKINSON MEDICAL SYSTEMS 305270 9251667 30382903052708

    Patients

    Seq Age Sex Outcome Treatment
    1 Other