BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PRECISIONGLIDE NEEDLE 26G X 1/2 IN

    MDR report key: 10222479 · Received July 2, 2020

    Report

    Report Number
    1911916-2020-00591
    Event Type
    Malfunction
    Date Received
    July 2, 2020
    Date of Event
    June 2, 2020
    Report Date
    June 15, 2020
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMI
    UDI-DI
    30382903051114
    PMA / PMN Number
    K021475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER FACILITY NAME: (B)(6). (B)(4). INVESTIGATION SUMMARY: TWO SAMPLES WERE RECEIVED FOR INVESTIGATION. ONE SAMPLE CAME WITH NO PACKAGING BLISTER. A VISUAL INSPECTION WAS PERFORMED. IT HAS A PLASTIC SHIELD. IT HAS AN EXTRA NEEDLE ATTACHED TO THE OUTER SIDE OF THE PLASTIC HUB. IT IS VISIBLE EVEN WHEN THE PLASTIC SHIELD IS ASSEMBLED. A 3/16¿ IS EXPOSED. THE NEEDLE THAT IS APPROPRIATELY ASSEMBLED AT THE CENTER OF THE PLASTIC HUB IS STRAIGHT. THE SECOND SAMPLE CAME IN SEALED PACKAGING BLISTER; VISUAL INSPECTION WAS PERFORMED TOO; NO DEFECTS OR ISSUES WERE OBSERVED. THE PHOTO PROVIDED SHOWS THE NEEDLE ASSEMBLY WITH NO PLASTIC SHIELD AND THE DOUBLE NEEDLE. 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. INVESTIGATION CONCLUSION: THIS IS THE 1ST COMPLAINT FOR LOT # 9193541 FOR THIS TYPE OF DEFECT OR SYMPTOM. THERE WAS NO DOCUMENTATION FOR THIS TYPE OF DEFECT DURING THE ENTIRE PRODUCTION RUN OF THIS BATCH #. BASED ON THE INVESTIGATION AND THE SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER IS CONFIRMED. THIS LOT WAS PRODUCED FOR 1.09MM UNITS, THE CPM IS 1. WE WILL CONTINUE MONITORING THIS PRODUCT AND LOT. ROOT CAUSE DESCRIPTION: A POTENTIAL ROOT CAUSE CAN BE ATTRIBUTED TO THE ASSEMBLY LINE. THE PLASTIC HUB IS PLACED UNDER THE CANNULATOR THEN THE NEEDLE IS POSITIONED AND ASSEMBLED TO THE PLASTIC HUB ADDING THE WHITE EPOXY TO FIX IT; AFTER THAT, A PLASTIC HUB IS ASSEMBLED. IN THIS CASE, THE MISFEEDING OF THE CANNULATOR MAY HAVE INDUCED TO HAVE THE DOUBLE NEEDLE. RATIONALE: CAPA NOT REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF BD PRECISIONGLIDE¿ NEEDLES 26G X 1/2 IN EXPERIENCED THE NEEDLE POINT PENETRATING THROUGH THE SHIELD PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 305111 BATCH NO: 919354. THE EVENT HAPPEN IN THE NIGHT OF JUNE 2ND. WHEN NEEDLE OPENED, A SECOND NEEDLE WAS FOUND IN PACKAGE THAT HAD PENETRATED THE CAP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    686429 BD PRECISIONGLIDE NEEDLE 26G X 1/2 IN HYPODERMIC SINGLE LUMEN NEEDLE FMI BD MEDICAL (BD WEST) MEDICAL SURGICAL 305111 9193541 30382903051114

    Patients

    Seq Age Sex Outcome Treatment
    1 Other