BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAF-T-INTIMA IV CATHETER SAFETY SYSTEM

    MDR report key: 11236960 · Received January 27, 2021

    Report

    Report Number
    9610847-2021-00039
    Event Type
    Malfunction
    Date Received
    January 27, 2021
    Date of Event
    January 4, 2021
    Report Date
    March 29, 2021
    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

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVAL?: YES. D.10. RETURNED TO MANUFACTURER ON: 3/8/2021. H.6. INVESTIGATION: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED LOT NUMBER 0146975 AND 0233516. 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. TO AID IN THE INVESTIGATION OF THIS ISSUE, TWENTY-FOUR REPRESENTATIVE SAMPLES WERE RETURNED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. THE SAMPLES WERE FUNCTIONALLY TESTED AND THEY WERE ALL FOUND TO BE WITHIN SPECIFICATION WITH NO SIGNS OF DEFECT. BASED ON THE INVESTIGATION RESULTS, AN EXACT CAUSE RELATED TO THE MANUFACTURING PROCESS COULD NOT BE DETERMINED FOR THIS REPORTED INCIDENT. THIS IS THE FIRST COMPLAINT FOR NEEDLE DISENGAGEMENT DIFFICULT FOR MATERIAL 383318 & BATCH 0146975. THIS IS THE FIRST COMPLAINT FOR CATHETER SEPARATED BEFORE PLACEMENT ON MATERIAL 383318 & BATCH 0233516.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM FROM LOT 0233516 SEPARATED FROM THE NEEDLE WHEN OPENED, AND ANOTHER CATHETER FROM LOT 0146975 HAD DIFFICULT NEEDLE DISENGAGEMENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: "FIRST: CATHETER REMOVED FROM THE NEEDLE AS SOON AS IT IS OPENED. LOT NO. 0233516, EXPIRY DATE: 2024-08-31. SECOND: CATHETER INSERTED, WHEN WITHDRAWAL IT WAS IMPOSSIBLE TO REMOVE THE NEEDLE FROM THE CATHETER. LOT NO. 0149975, EXPIRY DATE 2024-05-31. CONSEQUENCE(S) OF THE EVENT ON YOUR ACTIVITY : FOR THE 1ST : LOSS OF TIME AND MATERIAL. FOR THE SECOND: PAIN FOR THE RESIDENT, RISK OF INFECTION, LOSS OF TIME. CONSEQUENCE(S) OF THE EVENT ON THE SAFETY OF PERSONS AND PROPERTY: DEFECTIVE EQUIPMENT, INVOLVING A LOSS OF TIME, PAIN RELATED TO THE NEED TO REPEAT THE ACT."

    Additional Manufacturer Narrative · 1

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 0233516, MEDICAL DEVICE EXPIRATION DATE: 2024-08-31, DEVICE MANUFACTURE DATE: 2020-09-08. MEDICAL DEVICE LOT #: 0146975, MEDICAL DEVICE EXPIRATION DATE: 2024-05-31, DEVICE MANUFACTURE DATE: 2020-06-26. 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 FROM LOT 0233516 SEPARATED FROM THE NEEDLE WHEN OPENED, AND ANOTHER CATHETER FROM LOT 0146975 HAD DIFFICULT NEEDLE DISENGAGEMENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: "FIRST: CATHETER REMOVED FROM THE NEEDLE AS SOON AS IT IS OPENED. LOT NO. 0233516 EXPIRY DATE: 2024-08-31. SECOND: CATHETER INSERTED, WHEN WITHDRAWAL IT WAS IMPOSSIBLE TO REMOVE THE NEEDLE FROM THE CATHETER. LOT NO. 0149975, EXPIRY DATE 2024-05-31. CONSEQUENCE(S) OF THE EVENT ON YOUR ACTIVITY : FOR THE 1ST : LOSS OF TIME AND MATERIAL. FOR THE SECOND: PAIN FOR THE RESIDENT, RISK OF INFECTION, LOSS OF TIME. CONSEQUENCE(S) OF THE EVENT ON THE SAFETY OF PERSONS AND PROPERTY: DEFECTIVE EQUIPMENT, INVOLVING A LOSS OF TIME, PAIN RELATED TO THE NEED TO REPEAT THE ACT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135457 BD SAF-T-INTIMA IV CATHETER SAFETY SYSTEM INTRAVASCULAR CATHETER FOZ BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. SEE SECTION H.10.

    Patients

    Seq Age Sex Outcome Treatment
    1