BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTIMA-II Y 24GAX0.75IN PRN/EC SLM

    MDR report key: 11033042 · Received December 17, 2020

    Report

    Report Number
    3006948883-2020-01006
    Event Type
    Malfunction
    Date Received
    December 17, 2020
    Date of Event
    November 17, 2020
    Report Date
    January 28, 2021
    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

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 0231222. 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, THE PHOTOGRAPH OF THE AFFECTED DEVICE THAT WAS PROVIDED DISPLAYED A LARGE BEND ORIGINATING AT THE ROOT OF THE CANNULA. THIS SUGGESTS A LARGE FORCE WAS APPLIED TO THE PACKAGING UNIT AFTER THE DEVICE HAD LEFT THE MANUFACTURING FACILITY, MOST LIKELY DURING SHIPPING. THE SHIPPING COMPANY HAS BEEN NOTIFIED OF THE SITUATION AND BD STANDARDS AND EXPECTATIONS HAVE BEEN RECOMMUNICATED. CAPA#1278509 WAS INITIATED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A INTIMA-II Y 24GAX0.75IN PRN/EC SLM BROKE AT THE CANNULA BEFORE USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPOTER: "ON (B)(6) 2020.WHEN THE NURSE PERFORMED PUNCTURE TREATMENT AS INSTRUCTED BY THE DOCTOR, THE INFUSION SET WAS OPENED, THE EXTERNAL CANNULA OF THE NEEDLE WAS NOT FIRMLY FIXED, AND IT FELL OFF TO THE GROUND IMMEDIATELY AFTER BEING TAKEN OUT OF THE OUTER PACKAGE, AND THE NEEDLE WAS BENT, SO IT WAS REPLACED IMMEDIATELY.". ADR# (B)(4).

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A INTIMA-II Y 24GAX0.75IN PRN/EC SLM BROKE AT THE CANNULA BEFORE USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPOTER: "ON (B)(6) 2020.WHEN THE NURSE PERFORMED PUNCTURE TREATMENT AS INSTRUCTED BY THE DOCTOR, THE INFUSION SET WAS OPENED, THE EXTERNAL CANNULA OF THE NEEDLE WAS NOT FIRMLY FIXED, AND IT FELL OFF TO THE GROUND IMMEDIATELY AFTER BEING TAKEN OUT OF THE OUTER PACKAGE, AND THE NEEDLE WAS BENT, SO IT WAS REPLACED IMMEDIATELY." ADR# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1496167 INTIMA-II Y 24GAX0.75IN PRN/EC SLM INTRAVASCULAR CATHETER FOZ BD (SUZHOU) 0231222

    Patients

    Seq Age Sex Outcome Treatment
    1