BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEEDLE FILTER 19X1-1/2 TW

    MDR report key: 9682045 · Received February 7, 2020

    Report

    Report Number
    1911916-2020-00109
    Event Type
    Malfunction
    Date Received
    February 7, 2020
    Date of Event
    November 21, 2019
    Report Date
    February 12, 2020
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    GAA
    UDI-DI
    30382903052005
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER. THE FOLLOWING FIELDS HAVE BEEN UPDATED. B.3- DATE OF EVENT (B)(6) 2019.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD NEEDLE FILTER 19X1-1/2 TW HAD A BROKEN NEEDLE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTED: BROKEN FILTER NEEDLE. THE AFFECTED COMPONENTS ASSOCIATED WITH THE SUBJECT COMPLAINT HAVE BEEN REQUESTED FOR RETURN IN SUPPORT OF THE INVESTIGATION. NO FILTER NEEDLE WAS RETURNED.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. INVESTIGATION SUMMARY: SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED ARE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT. 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 # 8052947 FOR THIS TYPE OF DEFECT OR SYMPTOM. THERE WAS NO DOCUMENTATION FOR THIS TYPE OF DEFECTS DURING THE ENTIRE PRODUCTION RUN OF THIS BATCH. ROOT CAUSE DESCRIPTION: UNDETERMINED. RATIONALE: CAPA NOT REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD NEEDLE FILTER 19X1-1/2 TW HAD A BROKEN NEEDLE DURING USE . THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTED: BROKEN FILTER NEEDLE. THE AFFECTED COMPONENTS ASSOCIATED WITH THE SUBJECT COMPLAINT HAVE BEEN REQUESTED FOR RETURN IN SUPPORT OF THE INVESTIGATION. NO FILTER NEEDLE WAS RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    146006 BD NEEDLE FILTER 19X1-1/2 TW FILTER NEEDLE GAA BD MEDICAL (BD WEST) MEDICAL SURGICAL 305200 8052947 30382903052005

    Patients

    Seq Age Sex Outcome Treatment
    1 Other