BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAF-T-INTIMA IV CATHETER SAFETY SYSTEM

    MDR report key: 10271522 · Received July 14, 2020

    Report

    Report Number
    9610847-2020-00209
    Event Type
    Malfunction
    Date Received
    July 14, 2020
    Date of Event
    June 23, 2020
    Report Date
    November 9, 2020
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FOZ
    UDI-DI
    30382903833130
    PMA / PMN Number
    K013800
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    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: 8/6/2020. H.6. INVESTIGATION: A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR PROVIDED LOT NUMBER 9143632 AND THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS REPORTED INCIDENT. TO AID IN THE INVESTIGATION OF THIS ISSUE, FOURTEEN REPRESENTATIVE SAMPLES WERE RETURNED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. EACH OF THE REPRESENTATIVE SAMPLES WAS THOROUGHLY EXAMINED AND NO DAMAGES OR DEFECTS WERE OBSERVED. THREE DIFFERENT PULL TESTS WERE PERFORMED ON THE REPRESENTATIVE SAMPLES TO ENSURE PROPER FUNCTION AND ASSEMBLY. THESE TESTS WERE IN REGARDS TO THE CATHETER AND INSERTER ASSEMBLY, THE TUBE AND ADAPTER ASSEMBLY, AND THE STYLET AND NEEDLE ASSEMBLY. THROUGH THE TESTS, EACH SAMPLE APPEARED TO BE WITHIN SPECIFICATION IN ASSEMBLY AND NO SIGNS OF POSSIBLE DEFECTS OR LEAKAGE COULD BE IDENTIFIED. BASED ON THE INVESTIGATION RESULTS, A MANUFACTURING RELATED CAUSE COULD NOT BE DETERMINED FOR THIS REPORTED INCIDENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT CATHETERS ARE BREAKING DURING USE WITH A BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT CATHETERS ARE BREAKING DURING USE. ADDITIONALLY, ON 2020-07-02 THE CUSTOMER PROVIDED THE FOLLOWING ADDITIONAL INFORMATION: CATHETERS HAVE BROKEN IN THE POINT OF PULLING OUT NEEDLE THE CAP COMES FLYING OFF THAT'S ONE INCIDENT. ANOTHER INCIDENT WAS WHEN THE NEEDLE ITSELF CAME OFF. ANOTHER INCIDENT IS WHEN IN THE MOMENT OF SETTING UP THE POWER INJECTOR THE PLASTIC TUBING LITERALLY BROKE. FOR MANY OF THESE SITUATIONS THERE WAS BLOOD SPILLING FROM THE PATIENT WHICH REQUIRED EXTRA TIME IN CLEANING.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. (B)(6). 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 CATHETERS ARE BREAKING DURING USE WITH A BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT CATHETERS ARE BREAKING DURING USE. ADDITIONALLY, ON (B)(6) 2020 THE CUSTOMER PROVIDED THE FOLLOWING ADDITIONAL INFORMATION: CATHETERS HAVE BROKEN IN THE POINT OF PULLING OUT NEEDLE THE CAP COMES FLYING OFF THAT'S ONE INCIDENT. ANOTHER INCIDENT WAS WHEN THE NEEDLE ITSELF CAME OFF. ANOTHER INCIDENT IS WHEN IN THE MOMENT OF SETTING UP THE POWER INJECTOR THE PLASTIC TUBING LITERALLY BROKE. FOR MANY OF THESE SITUATIONS THERE WAS BLOOD SPILLING FROM THE PATIENT WHICH REQUIRED EXTRA TIME IN CLEANING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    738034 BD SAF-T-INTIMA IV CATHETER SAFETY SYSTEM INTRAVASCULAR CATHETER FOZ BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 383313 9143632 30382903833130

    Patients

    Seq Age Sex Outcome Treatment
    1 Other