BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PRECISIONGLIDE¿ NEEDLE

    MDR report key: 17916710 · Received October 11, 2023

    Report

    Report Number
    1911916-2023-00763
    Event Type
    Malfunction
    Date Received
    October 11, 2023
    Date of Event
    September 26, 2023
    Report Date
    November 1, 2023
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMI
    UDI-DI
    30382903051091
    PMA / PMN Number
    K021475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) FOLLOW UP FOR DEVICE EVALUATION. IT WAS REPORTED THERE WERE MULTIPLE DEFECTS WITH PRODUCT RECEIVED. TO AID IN THE INVESTIGATION, ELEVEN SAMPLES IN SEALED PACKAGING BLISTERS WERE RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. EIGHT SAMPLES WERE FROM LOT 2244830, TWO SAMPLES WERE FROM LOT 2222581 AND ONE SAMPLE WAS FROM LOT 2020910. A VISUAL INSPECTION WAS PERFORMED. FIVE SAMPLES WERE EMPTY PACKAGING BLISTERS, TWO SAMPLES HAD ONLY THE PLASTIC SHIELD, ONE PACKAGING BLISTER HAS TWO NEEDLE ASSEMBLIES IN IT, ONE UNIT HAS FOREIGN MATTER AT THE BOTTOM OF THE NEEDLE HUB AND TWO SAMPLES HAD NO DEFECTS OR IMPERFECTIONS. THESE DEFECTS COULD OCCUR IF THERE IS A JAM AT THE FEEDER DURING THE PACKAGING PROCESS. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER (B)(4), LOTS 2244830, 2222581 AND 2020910. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THESE LOTS THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. THERE WERE NO RELATED QUALITY NOTIFICATIONS. ALL PROCESSES AND FINAL INSPECTIONS COMPLIED WITH SPECIFICATION REQUIREMENTS. THE SAMPLES WILL BE SHOWN TO ASSOCIATES FOR AWARENESS. TO DATE, THERE HAVE BEEN NO OTHER SIMILAR EVENTS REPORTED FOR THESE LOTS. BASED ON THE INVESTIGATION AND WITH THE RETURNED SAMPLE ANALYSIS THE SYMPTOMS REPORTED BY THE CUSTOMER IS CONFIRMED.

    Additional Manufacturer Narrative · 0

    H.3. 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 · 0

    NO ADDITIONAL INFORMATION RECEIVED. IT WAS REPORTED THAT 3 OF THE BD PRECISIONGLIDE¿ NEEDLE HAD FOREIGN MATTER. THE FOLLOWING WAS RECEIVED FROM THE INITIAL REPORTER: 1 UNIT OF DIRTY NEEDLE. 2 UNITS OF DIRTY NEEDLES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 3 OF THE BD PRECISIONGLIDE¿ NEEDLE HAD FOREIGN MATTER. THE FOLLOWING WAS RECEIVED FROM THE INITIAL REPORTER: 1 UNIT OF DIRTY NEEDLE. 2 UNITS OF DIRTY NEEDLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2119928 BD PRECISIONGLIDE¿ NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BD MEDICAL (BD WEST) MEDICAL SURGICAL 2244830 30382903051091

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown