BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAFETYGLIDE¿ NEEDLE

    MDR report key: 17473442 · Received August 7, 2023

    Report

    Report Number
    1911916-2023-00555
    Event Type
    Malfunction
    Date Received
    August 7, 2023
    Date of Event
    June 30, 2023
    Report Date
    July 27, 2023
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMI
    UDI-DI
    30382903059059
    PMA / PMN Number
    K980987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: IT WAS REPORTED THE NEEDLE IS COVERED IN SOMETHING WHEN JUST OPENED FROM THE PACKAGE. TO AID IN THE INVESTIGATION, ONE SAMPLE IN AN OPENED PACKAGING BLISTER AND ONE PHOTO WAS PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. A VISUAL INSPECTION WAS PERFORMED, THE NEEDLE HAS DUST PARTICLES ADHERED TO THE LUBRICANT THAT COVERS THE NEEDLE. THE PHOTO PROVIDED SHOWS THE SAMPLE RECEIVED. NO OTHER DEFECTS OR IMPERFECTIONS WERE OBSERVED. THIS DEFECT COULD OCCUR IF, AFTER A REPAIR OR EQUIPMENT MAINTENANCE, CLEANING WAS NOT EFFECTIVELY PERFORMED. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 305905, LOT 3081120. 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 SAMPLE WILL BE SHOWN TO ASSOCIATES FOR AWARENESS. 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. 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. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SAFETYGLIDE¿ NEEDLE IS COVERED IN SOMETHING WHEN FRESH OPENED FROM PACKAGE. THE FOLLOWING WAS RECEIVED FROM THE INITIAL REPORTER: NEEDLE IS COVERED IN SOMETHING WHEN FRESH OPENED FROM PACKAGE. RESPONSE RECEIVED ON (B)(6) 2023. IS THE FOREIGN MATTER ABLE TO BE REMOVED OR IS IT EMBEDDED IN THE NEEDLE? IT LOOKS LIKE ITS ON THE NEEDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1507794 BD SAFETYGLIDE¿ NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BD MEDICAL (BD WEST) MEDICAL SURGICAL 3081120 30382903059059

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown