BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IV SET TUR Y-TUBE

    MDR report key: 10237222 · Received July 6, 2020

    Report

    Report Number
    2243072-2020-01003
    Event Type
    Malfunction
    Date Received
    July 6, 2020
    Date of Event
    June 15, 2020
    Report Date
    July 8, 2020
    Manufacturer
    BECTON DICKINSON
    Product Code
    FPA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    HE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10 DEVICE AVAILABLE FOR EVAL YES, RETURNED TO MANUFACTURER ON: 2020(B)(6) H.6. INVESTIGATION SUMMARY 1 SAMPLE WERE RETURNED TO SBDM, LOT NUMBER IS 6001201. SBDM CHECKED THE COMPLAINT SAMPLES, THERE IS AN UNFORMED PINCH CLAMP, LIKELY OCCURRED DURING INJECTION PROCESS. WHEN INJECTION PROCESS WAS STARTED THE CONDITION OF THE PROCESS WAS NOT PROPER TEMPORARILY. UNFORMED PINCH CLAMP LOCK TEST: SBDM TEST THE PINCH CLAMP AFTER PUSH FOR 2 SECONDS, THE PINCH CLAMP IS LOCKED EVEN IT IS NOT PROPERLY FORMED IN INJECTION PROCESS. HOUSE SAMPLE INSPECTION: SBDM INSPECTED 15 PCS FROM LOT 6912231, 6001201 AND 6002031, ALL COMPONENTS ARE PROPERLY FORMED ON THE HOUSE SAMPLES. DHR REVIEW: SBDM REVIEWED THE MANUFACTURING RECORD FOR LOT 6001201, NO ABNORMALITY OBSERVED. IN ADDITION, SBDM INSPECTED 30 INJECTION SHOTS OF CURRENT CLAMP INJECTION COMPONENTS AND THERE WAS NO ISSUE FOR ALL. CUSTOMER COMPLAINT RECORD REVIEW: SBDM REVIEWED THE CUSTOMER COMPLAINT RECORD OF COMPLAINT SAMPLE, THERE WAS SIMILAR COMPLAINTS FROM OTHER CUSTOMERS. ROOT CAUSE: 1 SAMPLE WAS RETURNED TO SBDM. BASED ON THE INVESTIGATION RESULT, THE LIKELY CAUSE MAY BE OCCURRED DURING CLAMP INJECTION PROCESS. ACCORDING TO THE INVESTIGATION BY RECEIVED COMPLAINT SAMPLES, THE CAVITY NUMBER OF UNFORMED CLAMPS IS CAVITY NO.2. IT IS LIKELY THERE WOULD BE RAW MATERIAL POWDER STOCK PROBLEM ON THE CAVITY NO.2.. 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. ANOTHER POSSIBILITY IS WHEN INJECTION PROCESS WAS STARTED THE CONDITION OF THE PROCESS WAS NOT PROPER TEMPORALLY, CAUSING THE UNFORMED CLAMP ISSUE. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE IV SET TUR Y-TUBE CLAMP WAS DEFECTIVE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "DEFECTED CLAMP"

    Additional Manufacturer Narrative · 1

    OEM MANUFACTURER: THE MANUFACTURING LOCATION FOR THIS PRODUCT IS (B)(4). THIS SITE IS AN OEM MANUFACTURING SITE. THEREFORE, BD CORPORATE HEADQUARTERS IN FRANKLIN LAKES, NJ HAS BEEN LISTED AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IV SET TUR Y-TUBE CLAMP WAS DEFECTIVE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "DEFECTED CLAMP."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    695554 IV SET TUR Y-TUBE INTRAVASCULAR ADMINISTRATION SET FPA BECTON DICKINSON 6001201

    Patients

    Seq Age Sex Outcome Treatment
    1 Other