BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ SYRINGE WITH BD LUER-LOK¿ TIP WITH NEEDLE

    MDR report key: 7889593 · Received September 19, 2018

    Report

    Report Number
    1911916-2018-00512
    Event Type
    Malfunction
    Date Received
    September 19, 2018
    Date of Event
    August 27, 2018
    Report Date
    November 8, 2018
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMI
    UDI-DI
    30382903051220
    PMA / PMN Number
    K021475
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: FIVE NEEDLES WERE RETURNED. THE COMPLAINT MENTIONED ¿PLASTIC HANGING OFF THE NEEDLE WHERE THE HUB CONNECTS TO THE SYRINGE. IT WILL BE HANGING NEAR THE NEEDLE.¿ TWO 25 X 5/8 NEEDLES FROM BATCHES 7264585 AND 7050622 WERE RETURNED, ALONG WITH TWO 18 X 1 NEEDLES FROM BATCHES 6028741 AND 8025603, AND ONE 18 X 1 ½ NEEDLE ATTACHED TO A SYRINGE. A VISUAL INSPECTION OF THE NEEDLES DID NOT SHOW ANY DEFECTS THEREFORE FAILURE MODE IS NOT CONFIRMED. 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. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED. ASSEMBLY BATCH 7024730: A VISUAL INSPECTION WAS PERFORMED ON (B)(4) PARTS WITH ZERO DEFECTS NOTED. CLEANING WAS PERFORMED 15 TIMES PER PROCEDURE. ASSEMBLY BATCH 6363959: A VISUAL INSPECTION WAS PERFORMED ON (B)(4) PARTS WITH ZERO DEFECTS NOTED. CLEANING WAS PERFORMED 11 TIMES PER PROCEDURE. NO QUALITY NOTIFICATIONS WERE WRITTEN FOR THIS BATCH, NOR FOR THE ASSOCIATED ASSEMBLY BATCHES.

    Description of Event or Problem · 0

    IT WAS REPORTED WITH THE USE OF THE BD¿ SYRINGE WITH BD LUER-LOK¿ TIP WITH NEEDLE THERE WAS AN ISSUE WITH FOREIGN MATTER. THERE WAS NO REPORT OF 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 WITH THE USE OF THE BD¿ SYRINGE WITH BD LUER-LOK¿ TIP WITH NEEDLE THERE WAS AN ISSUE WITH FOREIGN MATTER. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    732663 BD¿ SYRINGE WITH BD LUER-LOK¿ TIP WITH NEEDLE SYRINGE WITH HYPODERMIC NEEDLE FMI BD MEDICAL (BD WEST) MEDICAL SURGICAL 7058622 30382903051220

    Patients

    Seq Age Sex Outcome Treatment
    1 Other