BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    10 ML BD LUER-LOK¿ SYRINGE WITH 20 G X 1 IN. BD PRECISIONGLIDE¿ NEEDLE

    MDR report key: 8224195 · Received January 7, 2019

    Report

    Report Number
    1213809-2018-00968
    Event Type
    Malfunction
    Date Received
    January 7, 2019
    Date of Event
    December 17, 2018
    Report Date
    April 25, 2019
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096443
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: ONE 10ML SYRINGE WITH A SHIELDED NEEDLE ATTACHED WAS RECEIVED INSIDE AN OPENED BLISTER PACKAGE FROM BATCH #8192989 (P/N 309644). THE SAMPLE WAS VISUALLY EVALUATED. THE NEEDLE¿S CANNULA WAS OBSERVED TO BE COVERED IN NUMEROUS WHITE FIBER FOREIGN MATTER PARTICLES. THE SHIELD WAS CAREFULLY TAKEN OFF. THE WHITE FIBERS WERE COVERING THE ENTIRE LENGTH OF THE CANNULA FROM TIP TO HUB AS WELL AS THE INSIDE OF THE SHIELD. THE FM WAS LARGER THAN LEVEL 3 IN SIZE. THE AMOUNT OF FM OBSERVED IS REJECTABLE PER PRODUCT SPECIFICATION. ADDITIONAL INVESTIGATION WAS PERFORMED ON THE RETURNED SAMPLE WHICH WAS RECEIVED WITH THE NEEDLE SHIELD COVERING THE NEEDLE. THE NEEDLE SHIELD WAS REMOVED AND IT WAS OBSERVED THAT THERE IS LOOSE WHITE PLASTIC ON THE NEEDLE AND IN THE NEEDLE SHIELD. THIS IS LIKELY FROM THE RESULT OF A NEEDLE SHIELD THAT WAS FOUND ON THE FLOOR AND ACCIDENTALLY PLACED IN WITH THE GOOD PARTS INSTEAD OF THE WASTE PARTS. THIS NEEDLE SHIELD THEN WAS SHIELDED ON A NEEDLE. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A 10 ML BD LUER-LOK¿ SYRINGE WITH 20 G X 1 IN. BD PRECISIONGLIDE¿ NEEDLE WAS COVERED WITH PLASTIC SHAVINGS.

    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 10 ML BD LUER-LOK¿ SYRINGE WITH 20 G X 1 IN. BD PRECISIONGLIDE¿ NEEDLE WAS COVERED WITH PLASTIC SHAVINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    17547 10 ML BD LUER-LOK¿ SYRINGE WITH 20 G X 1 IN. BD PRECISIONGLIDE¿ NEEDLE SYRINGE WITH NEEDLE FMF BECTON DICKINSON MEDICAL SYSTEMS 8192989 30382903096443

    Patients

    Seq Age Sex Outcome Treatment
    1 Other