BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IV SET TUR Y-TUBE

    MDR report key: 9946191 · Received April 9, 2020

    Report

    Report Number
    2243072-2020-00586
    Event Type
    Malfunction
    Date Received
    April 9, 2020
    Date of Event
    March 17, 2020
    Report Date
    May 12, 2020
    Manufacturer
    BECTON DICKINSON
    Product Code
    FPA
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10 DEVICE AVAILABLE FOR EVAL YES, RETURNED TO MANUFACTURER ON: 2020-03-25 H.6. INVESTIGATION SUMMARY A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 6911041 THERE IS NO ISSUE WHILE MANUFACTURING. 1 SAMPLE WAS RETURNED TO SBDM. SBDM CHECKED THE COMPLAINT SAMPLE AND FOUND THAT UNFORMED PINCH CLAMP FROM THE RECEIVED COMPLAINT SAMPLE. BASED ON THE INVESTIGATION RESULT, THE LIKELY CAUSE IS THAT IT MAY OCCURRED DURING CLAMP INJECTION PROCESS. SBDM RECEIVED ONE COMPLAINT SAMPLE FOR PIR 3012348, 3012349 AND 3012350. IT SHOWS CAVITY NUMBER OF UNFORMED CLAMP IS CAVITY NO.2. LIKELY CAUSE FOR UNFORMED CLAMP IS, THE CLAMP IS INJECTED IN HIGH TEMPERATURE (200~240) AND INJECTION GAS WAS NOT EMITTED PROPERLY SO, THE GAS WAS ACCUMULATED IN THE END POINT OF CLAMP AND IT CAUSED THE COMPLAINT CASE. OR WHEN INJECTION PROCESS WAS STARTED THE CONDITION OF THE PROCESS WAS NOT PROPER TEMPORALLY. SO, THE UNFORMED CLAMP ISSUE WAS OCCURRED, AND IT CAUSED THE COMPLAINT CASE. HOUSE SAMPLE INSPECTION: SBDM INSPECTED 15 PCS FROM LOTS 6910281, 6911041 & 6911081, NO ABNORMALITY OBSERVED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE IV SET TUR Y-TUBE CLAMP WASN'T LOCKED BEFORE USE, CAUSING DRUG TO LEAK OUT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CLAMP NOT LOCKED - CLAMPS ARE NOT LOCKED AND DRUGS ARE LEAKING".

    Additional Manufacturer Narrative · 1

    OEM MANUFACTURER: THE MANUFACTURING LOCATION FOR THIS PRODUCT IS GREATER ASIA. THIS SITE IS AN OEM MANUFACTURING SITE. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. 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 THE IV SET TUR Y-TUBE CLAMP WASN'T LOCKED BEFORE USE, CAUSING DRUG TO LEAK OUT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CLAMP NOT LOCKED - CLAMPS ARE NOT LOCKED AND DRUGS ARE LEAKING."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    409250 IV SET TUR Y-TUBE INTRAVASCULAR ADMINISTRATION SET FPA BECTON DICKINSON 6911041

    Patients

    Seq Age Sex Outcome Treatment
    1 Other