BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK SYRINGE WITH BD PRECISIONGLIDE NEEDLE COMBO

    MDR report key: 8540568 · Received April 23, 2019

    Report

    Report Number
    1213809-2019-00462
    Event Type
    Malfunction
    Date Received
    April 23, 2019
    Date of Event
    April 8, 2019
    Report Date
    June 4, 2019
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903095750
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 0

    SEVEN 3ML SYRINGES WITH NEEDLES IN OPENED BLISTER PACKS FROM BATCH #9021695 (P/N 309575) WERE RECEIVED AND EVALUATED. IT APPEARED THE "LIQUID" WAS SILICONE AND WAS THE EXPECTED AND NORMAL AMOUNT PER PRODUCT SPECIFICATION. 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. 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. ROOT CAUSE NOT DEFINED SINCE DEFECTS WERE NOT CONFIRMED IN THE SAMPLES RECEIVED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT LIQUID LEAKED PAST THE STOPPER AND GOT INTO THE BD LUER-LOK¿ SYRINGE WITH BD PRECISIONGLIDE¿ NEEDLE COMBO BARREL WHEN PULLING BACK THE PLUNGER DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PHARMACIST REPORTED WHEN THEY PULL THE PLUNGER NOTICED LIQUID IN THE BARREL CLOSE TO THE STOPPER."

    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 THAT LIQUID LEAKED PAST THE STOPPER AND GOT INTO THE BD LUER-LOK¿ SYRINGE WITH BD PRECISIONGLIDE¿ NEEDLE COMBO BARREL WHEN PULLING BACK THE PLUNGER DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PHARMACIST REPORTED WHEN THEY PULL THE PLUNGER NOTICED LIQUID IN THE BARREL CLOSE TO THE STOPPER."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335369 BD LUER-LOK SYRINGE WITH BD PRECISIONGLIDE NEEDLE COMBO PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 9021695 30382903095750

    Patients

    Seq Age Sex Outcome Treatment
    1 Other