BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PRECISIONGLIDE¿ NEEDLE

    MDR report key: 7806762 · Received August 22, 2018

    Report

    Report Number
    1911916-2018-00461
    Event Type
    Malfunction
    Date Received
    August 22, 2018
    Date of Event
    August 1, 2018
    Report Date
    September 7, 2018
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMI
    UDI-DI
    30382903051978
    PMA / PMN Number
    K021475
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DUE TO AN IT ISSUE BEGINNING ON (B)(6) 2018, PREVIOUSLY FILED EMDRS DID NOT CONTAIN REQUIRED FIELDS. THIS SUPPLEMENTAL EMDR IS FILED TO PROVIDE THE FOLLOWING OMITTED FIELDS: EVENT ATTRIBUTED TO: OTHER. DEVICE SINGLE USE?: NO. DEVICE RETURNED TO MANUFACTURE: YES. INVESTIGATION SUMMARY: TWO NEEDLES WERE RETURNED IN OPENED PACKAGES. BOTH NEEDLES HAVE CRACKED SHIELDS, AND THE ONE NEEDLE HAS THE HUB PUSHED INTO THE SHIELD UP TO THE EARS OF THE HUB THEREFORE FAILURE MODE IS VERIFIED. DURING PACKAGING, NEEDLES ARE BLOWN INTO THE BLISTERS THROUGH FEEDER TUBES, INTO BOMB BAYS. IF THE AIR PRESSURE BLOWING THE NEEDLES OVER IS TOO HIGH, IT CAN CAUSE THE NEEDLE TO BE JAMMED INTO THE SHIELD CAUSING THE CRACKED SHIELDS SEEN. DUE TO THE LOW INCIDENT RATE FOR THIS TYPE OF DEFECT, NO CORRECTIVE ACTION WILL BE INITIATED AT THIS TIME. 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 8090641: A VISUAL INSPECTION WAS PERFORMED ON 11,650 PARTS WITH ZERO DEFECTS NOTED. 33 LEAK TESTS WERE PERFORMED ON 165 PARTS WITH ZERO FAILURES. NO QUALITY NOTIFICATIONS WERE WRITTEN FOR THIS BATCH, NOR FOR THE ASSOCIATED ASSEMBLY BATCHES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A BD PRECISIONGLIDE¿ NEEDLE HAD A HUB AND CAP THAT WERE CRACKED. THERE WAS NO REPORT OF EXPOSURE, SERIOUS 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 A BD PRECISIONGLIDE¿ NEEDLE HAD A HUB AND CAP THAT WERE CRACKED. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    645625 BD PRECISIONGLIDE¿ NEEDLE NEEDLE FMI BD MEDICAL (BD WEST) MEDICAL SURGICAL 8047617 30382903051978

    Patients

    Seq Age Sex Outcome Treatment
    1 Other