BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM

    MDR report key: 9587266 · Received January 14, 2020

    Report

    Report Number
    3006948883-2020-00006
    Event Type
    Injury
    Date Received
    January 14, 2020
    Date of Event
    May 20, 2019
    Report Date
    March 6, 2020
    Manufacturer
    BD (SUZHOU)
    Product Code
    FOZ
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: PHLEBITIS: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 8233335. 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. ADDITIONALLY, A SAMPLE COULD NOT BE OBTAINED FOR EVALUATION AND TESTING, BUT THIS LOT WAS TREATED AND RECEIVED A CERTIFICATE OF CONFORMANCE FOR STERILITY. 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 PHLEBITIS OCCURRED DURING USE WITH A BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "THE PATIENT WAS ADMITTED TO HOSPITAL ON (B)(6) 2019. IN ORDER TO REDUCE THE PAIN OF PUNCTURING AND PROTECT THE BLOOD VESSELS OF THE PATIENT, THE PATIENT RECEIVED INTRAVENOUS INFUSION WITH INDWELLING NEEDLE ON THE DAY OF ADMISSION AND PLACED IN THE LEFT FOREARM. THE DRESSING WAS CLEAN AND DRY. ON MAY 20TH, AFTER THE INFUSION TO PULL OUT THE NEEDLE, THE SECOND DAY THE PATIENT TOLD THE NURSE TO THE PAIN , WHEN THE PATIENT IS DISCHARGED FROM HOSPITAL, WHEN THE NURSE TO SEE TO THE 5 * 4 CM SKIN REDNESS, TOUCH THE PAIN, THE FEELING OF PAIN FOR SCORE 2 POINTS, EMBROCATED HIRUDOID, ON MAY 24TH, TO THE PATIENTS WITH SKIN REDNESS, TOUCH 2 * 2 CM OF SMALL SCLEROMA, CONTINUE TO EMBROCATE HIRUDOID, THE SCLEROMA STILL EXISTED ON MAY 27TH. TREATMENT WAS CONTINUED AND FOLLOW-UP WAS CONDUCTED."

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PHLEBITIS OCCURRED DURING USE WITH A BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "THE PATIENT WAS ADMITTED TO HOSPITAL ON (B)(6) 2019. IN ORDER TO REDUCE THE PAIN OF PUNCTURING AND PROTECT THE BLOOD VESSELS OF THE PATIENT, THE PATIENT RECEIVED INTRAVENOUS INFUSION WITH INDWELLING NEEDLE ON THE DAY OF ADMISSION AND PLACED IN THE LEFT FOREARM. THE DRESSING WAS CLEAN AND DRY. ON (B)(6), AFTER THE INFUSION TO PULL OUT THE NEEDLE, THE SECOND DAY THE PATIENT TOLD THE NURSE TO THE PAIN , WHEN THE PATIENT IS DISCHARGED FROM HOSPITAL, WHEN THE NURSE TO SEE TO THE 5 * 4 CM SKIN REDNESS, TOUCH THE PAIN, THE FEELING OF PAIN FOR SCORE 2 POINTS, EMBROCATED HIRUDOID, ON (B)(6), TO THE PATIENTS WITH SKIN REDNESS, TOUCH 2 * 2 CM OF SMALL SCLEROMA, CONTINUE TO EMBROCATE HIRUDOID, THE SCLEROMA STILL EXISTED ON (B)(6). TREATMENT WAS CONTINUED AND FOLLOW-UP WAS CONDUCTED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    50641 BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ BD (SUZHOU) 8233335

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention