BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PRECISIONGLIDE NEEDLE

    MDR report key: 10624144 · Received October 3, 2020

    Report

    Report Number
    1911916-2020-00925
    Event Type
    Malfunction
    Date Received
    October 3, 2020
    Date of Event
    August 30, 2020
    Report Date
    September 15, 2020
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMI
    UDI-DI
    30382903051107
    PMA / PMN Number
    K021475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION SUMMARY: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED MATERIAL NUMBER 305110 AND LOT NUMBER 9193538. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. AS A SAMPLE WAS UNAVAILABLE FOR RETURN, A THOROUGH SAMPLE INVESTIGATION COULD NOT BE COMPLETED. BASED ON THE INVESTIGATION RESULTS, AN EXACT CAUSE FOR THIS INCIDENT COULD NOT BE IDENTIFIED. INVESTIGATION CONCLUSION: NO SAMPLES WERE RECEIVED. NO PHOTOS WERE PROVIDED; THEREFORE, SAMPLE ANALYSIS COULD NOT BE PERFORMED, AND THE SYMPTOM REPORTED BY THE CUSTOMER COULDN¿T BE CONFIRMED. A REVIEW OF THE APPLICABLE FMEA/EURA ((B)(4)) INDICATES THAT THE POTENTIAL RISK OF THE REPORTED EVENT WAS ASSESSED APPROPRIATELY IN THE RISK MANAGEMENT DOCUMENTATION. ROOT CAUSE DESCRIPTION: WITHOUT A SAMPLE NO ANALYSIS CAN BE PERFORMED; THEREFORE, PROBABLE ROOT CAUSE CAN¿T BE OFFERED. RATIONALE: BASED ON THE INVESTIGATION AND WITH NO SAMPLE TO ANALYZE OR PHOTO SHOWING THE SYMPTOM REPORTED BY THE CUSTOMER, THE SYMPTOM CAN¿T BE CONFIRMED. NO ADDITIONAL ACTIONS WILL BE TAKEN OTHER THAN MONITORING THE COMPLAINT TREND FOR THIS LOT. THIS LOT WAS PRODUCED FOR 1.5MM UNITS, THIS A CPM OF (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT INSULIN LEAKED FROM THE BD PRECISIONGLIDE¿ NEEDLE DURING USE. THIS COMPLAINT WAS CREATED TO CAPTURE THE 2ND OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CALLER REPORTED [THAT INSULIN WAS LEAKING OUT OF THE SYRINGE WHERE THE NEEDLE CONNECTS TO THE SYRINGE]".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1088654 BD PRECISIONGLIDE NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BD MEDICAL (BD WEST) MEDICAL SURGICAL 305110 9193538 30382903051107

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other