BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE FILTER 19X1-1/2 TW

    MDR report key: 8519577 · Received April 16, 2019

    Report

    Report Number
    1911916-2019-00390
    Event Type
    Malfunction
    Date Received
    April 16, 2019
    Date of Event
    March 29, 2019
    Report Date
    April 9, 2019
    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 · 1

    DATE OF EVENT: UNKNOWN. INVESTIGATION SUMMARY: ONE PHOTO WAS PROVIDED BY THE CUSTOMER FOR INVESTIGATION. BY OUR QUALITY TEAM. UPON VISUAL INSPECTION, IT APPEARS TO SHOW A NEEDLE HUB WITH TWO (2) MARKS OR SCRATCHES ON THE HUB. HOWEVER, BASED ON THE PHOTO IT CANNOT BE DETERMINED IF THE MARKS OR SCRATCHES GO COMPLETELY THROUGH THE SIDE OF HUB AND IF THEY WOULD AFFECT THE FUNCTION OF THE NEEDLE HUB OR NOT. A DEVICE HISTORY RECORD REVIEW FOUND NO NON-CONFORMANCE'S ASSOCIATED WITH THIS ISSUE DURING PRODUCTION OF THIS BATCH. INVESTIGATION CONCLUSION: BASED ON THE QUALITY TEAM'S INVESTIGATION CONCLUSION AND THE PHOTO PROVIDED BY THE CUSTOMER, IT CANNOT BE DETERMINED IF THE APPEARS THAT THE MARKS OR SCRATCHES GO COMPLETELY THROUGH THE SIDE OF HUB AND WOULD AFFECT THE FUNCTION OF THE NEEDLE HUB OR NOT. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. ROOT CAUSE DESCRIPTION: THIS TYPE OF DAMAGE COULD OCCUR DURING THE MOLDING PROCESS OR DURING THE ASSEMBLY PROCESS; HOWEVER, IT CANNOT BE DEFINITELY DETERMINED WHERE THE DAMAGE OCCURRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE NEEDLE FILTER 19X1-1/2 TW EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 305200 , BATCH NO: 8052946. IT WAS REPORTED THAT THE HUB ON THE FILTER NEEDLE WAS FOUND TO BE CRACKED WHEN THE NEEDLE WAS WITHDRAWN FROM THE VIAL. EVENT DESCRIPTION PER CUSTOMER'S ATTACHED EMAIL STATES, "THE REPORTER REPORTED THAT THE HUB ON THE FILTER NEEDLE WAS CRACKED. COMPLAINT RECEIVED DATE: (B)(6) 2019". "THE DEFECT WAS NOTICED DURING USE (WITHDRAWAL FROM THE VIAL). THE MEDICATION WAS NOT ADMINISTERED TO THE PATIENT.".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310015 NEEDLE FILTER 19X1-1/2 TW MANUAL SURGICAL INSTRUMENT FOR GENERAL USE GAA BD MEDICAL (BD WEST) MEDICAL SURGICAL 8052946 30382903052005

    Patients

    Seq Age Sex Outcome Treatment
    1 Other