BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE-A BL 22GA X 1.16IN

    MDR report key: 14173972 · Received April 21, 2022

    Report

    Report Number
    3014704491-2022-00156
    Event Type
    Malfunction
    Date Received
    April 21, 2022
    Date of Event
    March 30, 2022
    Report Date
    May 8, 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
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 1222839. OUR RECORDS SHOW THAT THIS IS THE ONLY INSTANCE OF THIS ISSUE OCCURRING IN THIS PRODUCTION BATCH. ACCORDING TO THE SAMPLING PLAN APPLIED FOR PRODUCT PERFORMANCE, THIS LOT WAS ACCEPTED AND RELEASED WITHOUT DEFECTS BEING NOTED DURING THE FINAL ASSEMBLY OR VISUAL INSPECTIONS. UNFORTUNATELY, DUE TO CURRENT CUSTOMS LAW IN CHINA, THE AFFECTED DEVICE COULD NOT BE RETURNED TO THE MANUFACTURING FACILITY FOR EVALUATION. PHOTOGRAPHS WERE TAKEN OF THE AFFECTED DEVICE AND SUBMITTED TO THE FACILITY. OUR ENGINEERS WERE ABLE TO IDENTIFY DAMAGE TO THE BARREL OF THE SYRINGE AND A BENT GUIDEWIRE. THE ISSUE HAS BEEN CONFIRMED. A SUBSEQUENT REVIEW OF THE RETAINED SAMPLES FOR THIS LOT DID NOT IDENTIFY ANY ADDITIONAL INSTANCES OF THIS DAMAGE. BASED ON THE DAMAGE OBSERVED IN THE PHOTOGRAPH, AND THE UNAFFECTED RETENTIONS, OUR ENGINEERS BELIEVE THAT THE MOST LIKELY ROOT CAUSE IS RELATED TO DAMAGE DURING TRANSPORTATION OF THE DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD INSYTE-A BL 22GA X 1.16IN THE CATHETER HUB WAS CRACKED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER DISCOVERED THE FOLLOWING DEFECTS ON INSYTE A BEFORE USE. THE BARREL TIP/CATHETER HUB WAS CRACKED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD INSYTE-A BL 22GA X 1.16IN THE CATHETER HUB WAS CRACKED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER DISCOVERED THE FOLLOWING DEFECTS ON INSYTE A BEFORE USE. (1) THE BARREL TIP/CATHETER HUB WAS CRACKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1956814 BD INSYTE-A BL 22GA X 1.16IN INTRAVASCULAR CATHETER FOZ BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU 1222839

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown