BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAF-T-INTIMA IV CATHETER SAFETY SYSTEM

    MDR report key: 10570458 · Received September 22, 2020

    Report

    Report Number
    9610847-2020-00292
    Event Type
    Malfunction
    Date Received
    September 22, 2020
    Date of Event
    August 31, 2020
    Report Date
    October 2, 2020
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FOZ
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED LOT NUMBER 0062679. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. AS A SAMPLE WAS UNAVAILABLE FOR RETURN, A THOROUGH SAMPLE INVESTIGATION COULD NOT BE COMPLETED. BASED ON THE INVESTIGATION RESULTS, AN EXACT CAUSE FOR THIS INCIDENT COULD NOT BE IDENTIFIED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM SAFETY DEVICE DID NOT ENGAGE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: "WHEN INSERTING A CATHETER, THE SAFETY DEVICE DID NOT ENGAGE WHEN THE MANDREL WAS REMOVED. THE NEEDLE WAS THEREFORE REMOVED WITHOUT ANY PROTECTION, WHICH COULD HAVE LED TO A RISK OF PRICKING." "HAVE YOU OBSERVED ANY DAMAGE OR DEFECT ON THE CATHETER THAT MAY HAVE CAUSED THE REPORTED PROBLEM? NO. CAN THIS DEFECT BE DUE TO INCORRECT HANDLING? NO, BECAUSE THIS DEVICE HAS BEEN IN WIDESPREAD USE FOR MANY YEARS WITHOUT MALFUNCTIONING. HAVE YOU BEEN IN DIRECT CONTACT WITH THE PATIENT'S BLOOD OR THE PRODUCT USED? NO. IS THE INCRIMINATED DEVICE CONTAMINATED BY A DANGEROUS PRODUCT OR BLOOD? YES."

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM SAFETY DEVICE DID NOT ENGAGE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: "WHEN INSERTING A CATHETER, THE SAFETY DEVICE DID NOT ENGAGE WHEN THE MANDREL WAS REMOVED. THE NEEDLE WAS THEREFORE REMOVED WITHOUT ANY PROTECTION, WHICH COULD HAVE LED TO A RISK OF PRICKING." "HAVE YOU OBSERVED ANY DAMAGE OR DEFECT ON THE CATHETER THAT MAY HAVE CAUSED THE REPORTED PROBLEM? NO. CAN THIS DEFECT BE DUE TO INCORRECT HANDLING? NO, BECAUSE THIS DEVICE HAS BEEN IN WIDESPREAD USE FOR MANY YEARS WITHOUT MALFUNCTIONING. HAVE YOU BEEN IN DIRECT CONTACT WITH THE PATIENT'S BLOOD OR THE PRODUCT USED? NO. IS THE INCRIMINATED DEVICE CONTAMINATED BY A DANGEROUS PRODUCT OR BLOOD? YES."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1035743 BD SAF-T-INTIMA IV CATHETER SAFETY SYSTEM INTRAVASCULAR CATHETER FOZ BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 0062679

    Patients

    Seq Age Sex Outcome Treatment
    1 Other