BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SINGLE LUMEN NEEDLE, SYRINGE AND BLOOD COLLECTION SET

    MDR report key: 13563632 · Received February 18, 2022

    Report

    Report Number
    1911916-2022-00090
    Event Type
    Malfunction
    Date Received
    February 18, 2022
    Date of Event
    February 9, 2022
    Report Date
    March 2, 2022
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMI
    PMA / PMN Number
    K021475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A SAMPLE IS AVAILABLE FOR EVALUATION. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES. D10: RETURNED TO MANUFACTURER ON: 2022-02-25 . H6: INVESTIGATION SUMMARY IT WAS REPORTED TWO BAGS WERE IDENTIFIED MISSING THE INNER LABEL. TO AID IN THE INVESTIGATION, TWO BAGS WITH BULK PACKAGED PRODUCTS AND THREE PHOTOS WERE PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. A VISUAL INSPECTION WAS PERFORMED. THE PRODUCTS LOOKS GOOD, BUT NEITHER BAG HAS AN IDENTIFICATION LABEL. EACH PHOTO SHOWS NEEDLE ASSEMBLIES PACKAGED IN BULK PLASTIC BAGS. NO LABEL IS VISIBLE AT THE SIDE OF THE BAG SHOWN IN THE PHOTOS. NO OTHER DEFECTS OR IMPERFECTIONS WERE OBSERVED. THIS DEFECT COULD OCCUR IF, DURING THE PACKAGING PROCESS, ONLY THE OUTER LABEL WAS PLACED AND THE INNER LABEL WAS NOT ADDED. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 301643, LOT NUMBER 1172764. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. TO DATE, THERE HAVE BEEN NO OTHER SIMILAR EVENTS REPORTED FOR THIS LOT. BASED ON THE INVESTIGATION AND WITH THE RETURNED SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER IS CONFIRMED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD SINGLE LUMEN NEEDLE, SYRINGE AND BLOOD COLLECTION SET TWO BAGS WERE FOUND TO BE MISSING LABELS. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 301643 BATCH NO: 1172764 IT WAS REPORTED TWO BAGS WERE IDENTIFIED MISSING THE INNER LABEL.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD SINGLE LUMEN NEEDLE, SYRINGE AND BLOOD COLLECTION SET TWO BAGS WERE FOUND TO BE MISSING LABELS. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 301643 BATCH NO: 1172764 IT WAS REPORTED TWO BAGS WERE IDENTIFIED MISSING THE INNER LABEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    467797 BD SINGLE LUMEN NEEDLE, SYRINGE AND BLOOD COLLECTION SET HYPODERMIC SINGLE LUMEN NEEDLE FMI BD MEDICAL (BD WEST) MEDICAL SURGICAL 1172764

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown