BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PRECISIONGLIDE NEEDLE

    MDR report key: 10469387 · Received August 28, 2020

    Report

    Report Number
    1911916-2020-00830
    Event Type
    Malfunction
    Date Received
    August 28, 2020
    Date of Event
    August 6, 2020
    Report Date
    August 26, 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. THERE ARE QUALITY CONTROLS CURRENTLY IN PLACE TO DETECT THIS TYPE OF DEFECT DURING THE PRODUCTION PROCESS. FURTHER ACTION HAS NOT BEEN DETERMINED NECESSARY AT THIS TIME. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. OUR QUALITY TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. 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 (B)(4) UNITS, THIS A CPM OF 0.67.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT INSULIN LEAKED PAST THE BD PRECISIONGLIDE¿ NEEDLE AND SYRINGE CONNECTION DURING USE. THIS COMPLAINT WAS CREATED TO CAPTURE THE 2ND OF 3 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: 'CALLER REPORTED THAT THE INSULIN LEAKED THROUGH THE AREA WHERE THE NEEDLE AND SYRINGE CONNECT. CUSTOMER REPORTED THAT THE NEEDLE WAS SECURELY ATTACHED TO THE SYRINGE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    933709 BD PRECISIONGLIDE NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BD MEDICAL (BD WEST) MEDICAL SURGICAL 305110 9193538 30382903051107

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Other