BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTIMA-II Y 20GAX1.16IN PRN EC SLM NPVC

    MDR report key: 15272281 · Received August 22, 2022

    Report

    Report Number
    3014704491-2022-00370
    Event Type
    Malfunction
    Date Received
    August 22, 2022
    Date of Event
    August 10, 2022
    Report Date
    September 12, 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

    A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVAL: YES. D.10. RETURNED TO MANUFACTURER ON: 18-AUG-2022. H.6. INVESTIGATION SUMMARY: IN RESPONSE TO THE EVENT REPORTED BY THE FACILITY A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 1020902. 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. ADDITIONALLY, 15 SAMPLES WERE RETURNED. OF THESE, ONLY ONE SAMPLE DISPLAYED THE REPORTED CORROSION. THE ISSUE HAS BEEN CONFIRMED. BASED ON LEVEL OF DEGRADATION, AND ITS LOCATION, OUR ENGINEERS BELIEVES THAT THE ROOT CAUSE IS NOT RELATED TO THE MANUFACTURING PROCESS. CORROSION CAN OCCUR IF THE DEVICE IS STORED IN A LOCATION THAT IS EXPOSED TO HIGH HEAT OR AN OTHERWISE OXIDATIVE ENVIRONMENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING A BD INTIMA-II Y 20GAX1.16IN PRN EC SLM NPVC THE PRN OF ONE INDWELLING NEEDLE WAS MELTED AND THE TIP OF THE NEEDLE HAD RUST SPOTS AFTER OPENING THE PACKAGE. IT WAS REPORTED THE SAME TWO PROBLEMS WERE FOUND IN THE SUBSEQUENT INSPECTION OF 14 INDWELLING NEEDLES THAT WERE NOT OPENED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: THE EQUIPMENT TECHNICIAN REPORTED THAT THE PRN OF ONE INDWELLING NEEDLE WAS MELTED AND THE TIP OF THE NEEDLE HAD RUST SPOTS AFTER OPENING THE PACKAGE. THE SAME TWO PROBLEMS WERE FOUND IN THE SUBSEQUENT INSPECTION OF 14 INDWELLING NEEDLES THAT WERE NOT OPENED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING A BD INTIMA-II Y 20GAX1.16IN PRN EC SLM NPVC THE PRN OF ONE INDWELLING NEEDLE WAS MELTED AND THE TIP OF THE NEEDLE HAD RUST SPOTS AFTER OPENING THE PACKAGE. IT WAS REPORTED THE SAME TWO PROBLEMS WERE FOUND IN THE SUBSEQUENT INSPECTION OF 14 INDWELLING NEEDLES THAT WERE NOT OPENED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: THE EQUIPMENT TECHNICIAN REPORTED THAT THE PRN OF ONE INDWELLING NEEDLE WAS MELTED AND THE TIP OF THE NEEDLE HAD RUST SPOTS AFTER OPENING THE PACKAGE. THE SAME TWO PROBLEMS WERE FOUND IN THE SUBSEQUENT INSPECTION OF 14 INDWELLING NEEDLES THAT WERE NOT OPENED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2451143 INTIMA-II Y 20GAX1.16IN PRN EC SLM NPVC INTRAVASCULAR CATHETER FOZ BD (SUZHOU) 1020902

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown