BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAF-T-INTIMA¿ CLOSED IV CATHETER SYSTEM

    MDR report key: 14060678 · Received April 8, 2022

    Report

    Report Number
    3014704491-2022-00133
    Event Type
    Malfunction
    Date Received
    April 8, 2022
    Date of Event
    March 11, 2022
    Report Date
    March 23, 2022
    Manufacturer
    BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU
    Product Code
    FOZ
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO ACTUAL SAMPLE AND PICTURE RETURNED, THE SPECIFIC LEAKAGE POSITION OF INDWELLING NEEDLE COULD NOT BE DETERMINED. DHR REVIEW(LOT# 1051557): THE COMPLAINT GAUGE WAS 24G,ASSEMBLY AT AUTO LINE 4 IN APR. 2021,PACKAGING AT R245 PACKING MACHINE IN APR. 2021, LOT QUANTITY WAS (B)(4). REVIEW THE IN PROCESS TEST AND OUTGOING TEST REPORT FOR THIS LOT PRODUCT, ALL TEST RESULTS MET THE PRODUCT SPECIFICATIONS, NO ABNORMAL FOR IT. REVIEW THE PRODUCTION RECORDS AND MACHINE TROUBLESHOOTING RECORDS FOR THIS LOT PRODUCT, NO ABNORMALITY, DEVIATION OR REWORK ACTIVITY. LEAKAGE TEST THE RETAINED SAMPLE OF THIS BATCH, AND NO LEAKAGE WAS FOUND. PLEASE REFER TO THE ATTACHED TEST REPORT. NO SAME COMPLAINT WAS RECEIVED FROM THE COMPLAINT LOT. CONCLUSION(S): NO ABNORMAL FOUND ON PROCESS, AS NO DEFECTIVE SAMPLE RETURNED, FURTHER ANALYSIS COULD NOT BE DONE, THE ROOT CAUSE OF INDWELLING NEEDLE LEAKAGE COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SAF-T-INTIMA¿ CLOSED IV CATHETER SYSTEM HAD FLUID LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE CLIENT: "THE PATIENT WAS GIVEN VENIPUNCTURE, AND FLUID LEAKAGE FROM THE INDWELLING NEEDLE WAS FOUND DURING EXHAUSTING."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    187553 BD SAF-T-INTIMA¿ CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU 1051557

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown