BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM

    MDR report key: 15441574 · Received September 16, 2022

    Report

    Report Number
    3014704491-2022-00411
    Event Type
    Malfunction
    Date Received
    September 16, 2022
    Date of Event
    August 15, 2022
    Report Date
    September 6, 2022
    Manufacturer
    BD (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

    INITIAL REPORTER PHONE#: UNKNOWN. INITIAL REPORTER E-MAIL: UNKNOWN. INVESTIGATION SUMMARY: DHR REVIEW (LOT#1203528): THE COMPLAINT GAUGE IS 24G, ASSEMBLY AT AUTO LINE 2 IN AUG. 2021, PACKAGING AT CFS PACKING MACHINE IN AUG. 2021, BATCH QUANTITY IS 186K. REVIEW THE IN PROCESS TEST AND OUTGOING TEST REPORTS FOR THIS LOT PRODUCT, ALL TEST RESULTS MEET THE PRODUCT SPECIFICATIONS, NO ABNORMAL FOR IT. REVIEW THE PRODUCTION RECORDS FOR THIS LOT PRODUCT, NO NON-CONFORMANCE, DEVIATIONS OR REWORK ACTIVITIES. NO ACTUAL SAMPLES AND PICTURES WERE RETURNED FROM THE CUSTOMER, AND THE STATUS AND COMPOSITION OF THE BLACK SPOT CANNOT BE DETERMINED. CHECK THE RETAINED SAMPLES OF THIS BATCH AND FIND NO ABNORMALITY. CONCLUSION(S): NO ABNORMALITY IS FOUND ON PROCESS AND THE RETAINED SAMPLES, AS NO DEFECTIVE SAMPLE RETURNED, THE ROOT CAUSE OF THE BLACK SPOT ON THE INDWELLING NEEDLE HEAD CANNOT BE CONFIRMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A BLACK SPOT OF FOREIGN MATTER WAS FOUND ON THE BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM NEEDLE AFTER REMOVING IT FROM THE PACKAGING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6): "WHEN OPENED THE PACKAGE, IT WAS FOUND THAT THE NEEDLE HAD A BLACK SPOT, AND THE NEEDLE COULD NOT USE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125691 BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ BD (SUZHOU) 1203528

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown