BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PRECISIONGLIDE¿ NEEDLE

    MDR report key: 7481400 · Received May 2, 2018

    Report

    Report Number
    1911916-2018-00190
    Event Type
    Malfunction
    Date Received
    May 2, 2018
    Date of Event
    April 17, 2018
    Report Date
    June 13, 2018
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMI
    UDI-DI
    30382903051220
    PMA / PMN Number
    K021475
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THANK YOU FOR SENDING IN YOUR SAMPLE, HOWEVER WE ARE UNABLE TO LOCATE IT AT THIS TIME. 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 REVIEW WAS COMPLETED AND ZERO DEFECTS WERE NOTED DURING ALL THE LEAK TESTS PERFORMED. BATCH 6339781: ASSEMBLY BATCH 6299716 HAD 91 VISUAL INSPECTIONS PERFORMED ON 4,750 PARTS WITH TWO DEFECTS NOTED FOR LOW LUBE SOLIDS (ACCEPTED ON DEVIATION), AND EPOXY DRIPOVERS (SCRAPPED). ELEVEN LEAK TESTS WERE PERFORMED ON 55 PARTS WITH ZERO FAILURES RECORDED. BATCH 708752: ASSEMBLY BATCH 7059646 HAD 150 VISUAL INSPECTIONS PERFORMED ON 7,500 PARTS WITH ONE DEFECT NOTED FOR DISCOLORED SHIELDS (STAT. SAMPLED AND ACCEPTED). TWENTY-PNE LEAK TESTS WERE PERFORMED ON 105 PARTS WITH ZERO FAILURES RECORDED. BATCH 6207976: ASSEMBLY BATCH 6209687 HAD 42 VISUAL INSPECTIONS PERFORMED ON 2,100 PARTS WITH ONE DEFECT NOTED FOR UNSHIELDED NEEDLES (SCRAPPED). SIX LEAK TESTS WERE PERFORMED ON 30 PARTS WITH ZERO FAILURES RECORDED. BATCH 5148888: ASSEMBLY BATCH 5119879 HAD 61 VISUAL INSPECTIONS PERFORMED ON 3,200 PARTS WITH ZERO DEFECTS NOTED. NINE LEAK TESTS WERE PERFORMED ON 45 PARTS WITH ZERO FAILURES RECORDED. BATCH 3061350: ASSEMBLY BATCH 3031201 HAD 74 VISUAL INSPECTIONS PERFORMED ON 3,700 PARTS WITH ZERO DEFECTS NOTED. ELEVEN LEAK TESTS WERE PERFORMED ON 55 PARTS WITH ZERO FAILURES RECORDED. NO QUALITY NOTIFICATIONS FOR LEAKAGE WERE WRITTEN FOR THESE BATCHES, NOR FOR THEIR ASSOCIATED ASSEMBLY BATCHES. BASED ON THE COMPLAINT TEXT, THE POSSIBLE ROOT CAUSE MAY BE THE WAY THE NEEDLES ARE BEING ATTACHED TO THE SYRINGE.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. 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 · 1

    IT WAS REPORTED THAT A BD PRECISIONGLIDE¿ NEEDLE LEAKED/SPRAYED DURING USE. THERE WAS NO REPORT OF EXPOSURE TO MUCOUS MEMBRANES, INJURY OR MEDICAL INTERVENTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    324408 BD PRECISIONGLIDE¿ NEEDLE HYPODERMIC NEEDLE FMI BD MEDICAL (BD WEST) MEDICAL SURGICAL 6339781 30382903051220

    Patients

    Seq Age Sex Outcome Treatment
    1 Other