BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM

    MDR report key: 8805376 · Received July 18, 2019

    Report

    Report Number
    3006948883-2019-00573
    Event Type
    Malfunction
    Date Received
    July 18, 2019
    Date of Event
    June 30, 2019
    Report Date
    August 19, 2019
    Manufacturer
    BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.
    Product Code
    FOZ
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBERS 81413670 & 8233312. OUR RECORDS SHOW THAT THIS IS THE ONLY INSTANCE OF THIS ISSUE OCCURRING IN EITHER PRODUCTION BATCH. ACCORDING TO THE SAMPLING PLAN APPLIED FOR PRODUCT PERFORMANCE, THESE LOTS WERE ACCEPTED AND RELEASED WITHOUT DEFECTS BEING NOTED DURING THE FINAL ASSEMBLY OR VISUAL INSPECTIONS. ALSO, A REPRESENTATIVE SAMPLES WAS SUBMITTED FOR EVALUATION; VISUAL OBSERVATION OF THE DEVICE WAS UNABLE TO IDENTIFY THE REPORTED NON-CONFORMANCE AND FURTHER DETERMINED THAT IT WAS NORMAL AND WITHIN PRODUCT SPECIFICATION. UNFORTUNATELY, WITHOUT THE ABILITY TO OBSERVE THE REPORTED NONCONFORMANCE BD WAS UNABLE TO DETERMINE A ROOT CAUSE FOR THIS EVENT. H3 OTHER TEXT : SEE SECTION H.10.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED THAT THE BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM HAS BEEN FOUND WITH THREE INSTANCES OF FOREIGN MATTER BEFORE USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: IT'S FOUND THAT THERE WAS A LARGE SHADOW ON THE SIDE HOLE OF THE NEEDLE TIP AFTER UNWRAPPED THE PACKAGE, AND CUSTOMER SUSPECTED THAT THE NEEDLE CORE WAS RUSTY. DEFECTED PRODUCT DIDN'T USED. N O PHYSICAL HARM TO THE END USER.

    Additional Manufacturer Narrative · 1

    MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 8141370, MEDICAL DEVICE EXPIRATION DATE: 2021-07-11, DEVICE MANUFACTURE DATE: 2018-05-21; MEDICAL DEVICE LOT #: 8233312, MEDICAL DEVICE EXPIRATION DATE: 2021-09-22, DEVICE MANUFACTURE DATE: 2018-08-21. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT THE BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM HAS BEEN FOUND WITH THREE INSTANCES OF FOREIGN MATTER BEFORE USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: IT'S FOUND THAT THERE WAS A LARGE SHADOW ON THE SIDE HOLE OF THE NEEDLE TIP AFTER UNWRAPPED THE PACKAGE, AND CUSTOMER SUSPECTED THAT THE NEEDLE CORE WAS RUSTY. DEFECTED PRODUCT DIDN'T USED. NO PHYSICAL HARM TO THE END USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    599467 BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM INTERVASCULAR CATHETER FOZ BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Other