BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTIMA-II Y 22GAX1.00IN PRN/EC SLM

    MDR report key: 10924517 · Received November 30, 2020

    Report

    Report Number
    3006948883-2020-00861
    Event Type
    Malfunction
    Date Received
    November 30, 2020
    Date of Event
    October 28, 2020
    Report Date
    December 15, 2020
    Manufacturer
    BD (SUZHOU)
    Product Code
    FOZ
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 0202492 . OUR RECORDS SHOW THAT THIS IS THE ONLY INSTANCE OF THIS ISSUE OCCURRING IN THIS PRODUCTION BATCH. ACCORDING TO THE SAMPLING PLAN APPLIED FOR PRODUCT PERFORMANCE, THIS LOT WAS ACCEPTED AND RELEASED WITHOUT DEFECTS BEING NOTED DURING THE FINAL ASSEMBLY OR VISUAL INSPECTIONS. A SAMPLE COULD NOT BE OBTAINED FOR EVALUATION AND TESTING; IN LIEU OF THE AFFECTED DEVICE, FUNCTIONAL TESTING WAS PERFORMED ON RETENTION SAMPLES FOR THIS LOT, THE RESULTS OF THESE SHOW THAT THE TESTED UNITS PERFORMED WITHIN PRODUCT SPECIFICATIONS. UNFORTUNATELY WITHOUT THE ABILITY TO INVESTIGATE THE AFFECTED UNIT OUR QUALITY ENGINEERS WERE UNABLE TO DETERMINE THE ROOT CAUSE FOR THIS COMPLAINT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT INTIMA-II Y 22GAX1.00IN PRN/EC SLM LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ON OCTOBER 28, 2020, THE MEDICAL STAFF FOUND THAT THE PATIENT'S BLOOD OOZED FROM THE PLASTIC JOINT OF THE INDWELLING NEEDLE WHEN THEY PERFORMED INTRAVENOUS PUNCTURE ON THE PATIENT, WHICH WAS A SERIOUS POTENTIAL INFECTION. THE MEDICAL STAFF IMMEDIATELY EXPLAINED AND REPLACED A NEW CLOSED VENOUS INDWELLING NEEDLE TO PERFORM INTRAVENOUS PUNCTURE ON THE PATIENT, RESULTING IN SECONDARY SKIN DAMAGE. THE INCIDENT HAD SERIOUS ADVERSE EFFECTS. THE MEDICAL STAFF REPORTED THE INCIDENT TO THE HEAD NURSE, WHO IMMEDIATELY REPORTED THE INCIDENT TO THE PROCUREMENT TEAM OF THE MEDICAL AND INDUSTRIAL DEPARTMENT FOR FOLLOW-UP TREATMENT.

    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT INTIMA-II Y 22GAX1.00IN PRN/EC SLM LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ON (B)(6) 2020, THE MEDICAL STAFF FOUND THAT THE PATIENT'S BLOOD OOZED FROM THE PLASTIC JOINT OF THE INDWELLING NEEDLE WHEN THEY PERFORMED INTRAVENOUS PUNCTURE ON THE PATIENT, WHICH WAS A SERIOUS POTENTIAL INFECTION. THE MEDICAL STAFF IMMEDIATELY EXPLAINED AND REPLACED A NEW CLOSED VENOUS INDWELLING NEEDLE TO PERFORM INTRAVENOUS PUNCTURE ON THE PATIENT, RESULTING IN SECONDARY SKIN DAMAGE. THE INCIDENT HAD SERIOUS ADVERSE EFFECTS. THE MEDICAL STAFF REPORTED THE INCIDENT TO THE HEAD NURSE, WHO IMMEDIATELY REPORTED THE INCIDENT TO THE PROCUREMENT TEAM OF THE MEDICAL AND INDUSTRIAL DEPARTMENT FOR FOLLOW-UP TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1384486 INTIMA-II Y 22GAX1.00IN PRN/EC SLM CATHETER FOZ BD (SUZHOU) 0202492

    Patients

    Seq Age Sex Outcome Treatment
    1