BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM

    MDR report key: 9226445 · Received October 23, 2019

    Report

    Report Number
    9610847-2019-00640
    Event Type
    Malfunction
    Date Received
    October 23, 2019
    Date of Event
    September 27, 2019
    Report Date
    December 17, 2019
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FOZ
    UDI-DI
    30382903833130
    PMA / PMN Number
    K013800
    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: LOT NUMBER PROVIDED IS NOT A VALID LOT FOR ANY BD PRODUCT. SINCE A VALID LOT NUMBER COULD NOT BE CONNECTED TO THE DEVICE IDENTIFIED IN THE COMPLAINT, BD INVESTIGATORS COULD NOT CONDUCT A DEVICE HISTORY REVIEW FOR THIS EVENT. ADDITIONALLY, A SAMPLE HAS NOT BEEN SUBMITTED FOR EVALUATION AND TESTING, PREVENTING BD ENGINEERS FROM CONDUCTING A FULL INVESTIGATION AND DETERMINING A ROOT CAUSE OF THE FAILURE MODE IDENTIFIED IN THE DESCRIPTION OF THE EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE NEEDLE HAD PIERCED THROUGH BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM BEFORE USE, AND THE EXTENSION TUBING WAS DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: "1. NEEDLE THROUGH CATHETER. 2. EXT. TUBING DAMAGED. 3. NEEDLE ENCASED IN CATHETER (THE LENGTH OF CATHETER IS LONGER THAN NEEDLE)(LIE DISTANCE INCORRECT)."

    Additional Manufacturer Narrative · 1

    ALTHOUGH THE REPORTED LOT # [8122736] HAS BEEN CONFIRMED TO BE CORRECT BY THE CUSTOMER, IT WAS NOT FOUND FOR THE REPORTED CATALOG # [383313] ON SAP. ONCE THE MANUFACTURE AND EXPIRATION DATES ARE PROVIDED BY THE CUSTOMER, A SUPPLEMENTAL REPORT WILL BE FILED. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE NEEDLE HAD PIERCED THROUGH BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM BEFORE USE, AND THE EXTENSION TUBING WAS DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: "1. NEEDLE THROUGH CATHETER . 2. EXT. TUBING DAMAGED. 3. NEEDLE ENCASED IN CATHETER (THE LENGTH OF CATHETER IS LONGER THAN NEEDLE)(LIE DISTANCE INCORRECT)".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1025414 BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM INTERVASCULAR CATHETER FOZ BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. UNKNOWN 30382903833130

    Patients

    Seq Age Sex Outcome Treatment
    1 Other