BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ BLUNT FILL NEEDLE WITH FILTER

    MDR report key: 9700379 · Received February 12, 2020

    Report

    Report Number
    1911916-2020-00140
    Event Type
    Malfunction
    Date Received
    February 12, 2020
    Date of Event
    January 23, 2020
    Report Date
    February 20, 2020
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    GAA
    UDI-DI
    30382903052111
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: 6 SAMPLES WERE RECEIVED. ONE CAME WITH NO PACKAGING BLISTER, THE OTHER 5 CAME IN SEALED PACKAGING BLISTER. THE ONE WITH NO PACKAGING HAS THE PLASTIC SHIELD AND THE PLASTIC SHIELD IS DAMAGED AT ABOUT ½¿ FROM THE TIP. THE NEEDLE IS BENT TOWARDS THE TIP. IT GOT BENT WHEN THE PLASTIC SHIELD GOT DAMAGED. FROM THE OTHER 5 SAMPLES, THREE HAD SIMILAR DAMAGE; TWO ARE GOOD WITH NO DEFECTS. NO OTHER DEFECTS WERE OBSERVED. ADDITIONALLY, FOUR PHOTOS WERE PROVIDED. THEY SHOW THE PLASTIC SHIELD DAMAGED AND THE NEEDLE BENT. THE PLASTIC HUB IS PLACED UNDER THE CANNULATOR. THEN THE NEEDLE IS POSITIONED AND ASSEMBLED TO THE PLASTIC HUB ADDING THE EPOXY TO ATTACH THEM. THEN THE PLASTIC SHIELD IS ASSEMBLED. IN THIS CASE THE PLASTIC SHIELD WAS ASSEMBLED AND THE MECHANICAL DEVICE THAT INSERTS IT IN THE PLASTIC HUB INDUCED THE DAMAGE AND NOT DETECTED IN THE NEXT PROCESSES. 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 WITH ZERO DEFECTS FOUND. NO QUALITY NOTIFICATIONS WERE WRITTEN FOR THIS BATCH, NOR FOR THE ASSOCIATED ASSEMBLY BATCHES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE TIP OF THE BD¿ BLUNT FILL NEEDLE WITH FILTER WAS FOUND DAMAGED BEFORE USE INSIDE THE PACKAGING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER HAS FOUND DAMAGED PRODUCTS INSIDE THE PACKAGE. OUTER BOX HASN¿T HAD ANY SIGNS OF DAMAGE."

    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 THE TIP OF THE BD¿ BLUNT FILL NEEDLE WITH FILTER WAS FOUND DAMAGED BEFORE USE INSIDE THE PACKAGING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER HAS FOUND DAMAGED PRODUCTS INSIDE THE PACKAGE. OUTER BOX HASN¿T HAD ANY SIGNS OF DAMAGE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    166959 BD¿ BLUNT FILL NEEDLE WITH FILTER MANUAL SURGICAL INSTRUMENT FOR GENERAL USE GAA BD MEDICAL (BD WEST) MEDICAL SURGICAL 305211 9129697 30382903052111

    Patients

    Seq Age Sex Outcome Treatment
    1 Other