BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAF-T-INTIMA PRN PNK 20GA X 1.0IN ROW

    MDR report key: 9835589 · Received March 16, 2020

    Report

    Report Number
    9610847-2020-00099
    Event Type
    Malfunction
    Date Received
    March 16, 2020
    Date of Event
    February 19, 2020
    Report Date
    April 1, 2020
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FOZ
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    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 PERFORMED FOR PROVIDED LOT NUMBER 9175123. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES THAT COULD HAVE CONTRIBUTED TO THIS REPORTED INCIDENT AND ALL INSPECTIONS WERE FOUND TO BE WITHIN SPECIFICATION. TO FURTHER INVESTIGATE THIS ISSUE, ONE PHYSICAL SAMPLE WAS PROVIDED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. HOWEVER, THE SAMPLE WAS UNAVAILABLE FOR EVALUATION DUE TO COVID-19 CONCERNS. A THOROUGH INVESTIGATION UTILIZING OTHER METHODOLOGIES AND AVAILABLE INFORMATION HAS BEEN COMPLETED TO THE BEST OF OUR ABILITY. TEN SAMPLES WERE OBTAINED FROM THE MANUFACTURING FACILITY IN AN ATTEMPT TO REPLICATE THE REPORTED INCIDENT; HOWEVER, THE TEN SAMPLES PERFORMED PER SPECIFICATION. A MANUFACTURING RELATED CAUSE COULD NOT BE DETERMINED FOR THIS INCIDENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SAF-T-INTIMA PRN PNK 20GA X 1.0IN ROW HAD A SAFETY MECHANISM FAILURE. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN THE NEEDLE WAS REMOVED FROM THE SUBCUTANEOUS CATHETER, THE SAFETY DID NOT ENGAGE.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SAF-T-INTIMA PRN PNK 20GA X 1.0IN ROW HAD A SAFETY MECHANISM FAILURE. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN THE NEEDLE WAS REMOVED FROM THE SUBCUTANEOUS CATHETER, THE SAFETY DID NOT ENGAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301575 SAF-T-INTIMA PRN PNK 20GA X 1.0IN ROW N/A FOZ BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 9175123

    Patients

    Seq Age Sex Outcome Treatment
    1 Other