BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MICROLANCE HYPODERMIC NEEDLE

    MDR report key: 16653043 · Received March 30, 2023

    Report

    Report Number
    1911916-2023-00192
    Event Type
    Malfunction
    Date Received
    March 30, 2023
    Date of Event
    March 12, 2023
    Report Date
    March 15, 2023
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EXPIRATION DATE: NA. INVESTIGATION SUMMARY: IT WAS REPORTED ONE BAG HAS NO IDENTIFICATION LABEL. TO AID IN THE INVESTIGATION, ONE PHOTO WAS PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. THE PHOTO SHOWS A PLASTIC BAG WITH NEEDLE ASSEMBLIES. NO LABEL IS VISUALIZED ON THAT SIDE OF THE BAG. NO OTHER INFORMATION COULD BE OBTAINED FROM THE PHOTO. IT COULD BE POSSIBLE AN ASSOCIATE MISSED PLACING THE LABEL ON THE BAG. IN ADDITIONAL TO THE LABEL ON THE BAG, A LABEL IS INCLUDED IN THE CASE BOX CONFIRMING THE PRODUCT AND LOT NUMBER. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 302047, LOT 0078355. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. THERE WERE NO RELATED QUALITY NOTIFICATIONS. ALL PROCESSES AND FINAL INSPECTIONS COMPLIED WITH SPECIFICATION REQUIREMENTS. THE PHOTO WILL BE SHOWN TO THE ASSOCIATES FOR AWARENESS. TO DATE, THERE HAVE BEEN NO OTHER SIMILAR EVENTS REPORTED FOR THIS LOT. BASED ON THE INVESTIGATION AND WITH THE PHOTO SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER IS 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD MICROLANCE HYPODERMIC NEEDLE HAD NO IDENTIFICATION LABEL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ON MARCH 12, 2023, DURING INCOMING INSPECTION FOR CAT. 9080101 NEEDLE 30GX1/2- USA LOT #00478355 WERE FOUND: ONE BAG HAS NO IDENTIFICATION LABEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    580094 BD MICROLANCE HYPODERMIC NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BD MEDICAL (BD WEST) MEDICAL SURGICAL 0078355

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown