BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PPICC 5FR,D/L, 3CG

    MDR report key: 15075641 · Received July 21, 2022

    Report

    Report Number
    3006260740-2022-02855
    Event Type
    Malfunction
    Date Received
    July 21, 2022
    Date of Event
    June 29, 2022
    Report Date
    August 5, 2022
    Manufacturer
    C.R. BARD, INC. (BASD) -3006260740
    Product Code
    LJS
    PMA / PMN Number
    K051672
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER HAS RECEIVED THE SAMPLE AND IS PENDING EVALUATION. RESULTS ARE EXPECTED SOON. A LOT HISTORY REVIEW (LHR) OF REFY3640 SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER.

    Additional Manufacturer Narrative · 0

    H11: SECTION A THROUGH F THE INFORMATION PROVIDED BY BD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD. THE FOLLOWING WERE REVIEWED AS PART OF THIS INVESTIGATION: PATIENT SEVERITY, TREND ANALYSIS, APPLICABLE PREVIOUS INVESTIGATION(S), SAMPLE (IF AVAILABLE), AND APPLICABLE FMEA DOCUMENTS. BASED ON A REVIEW OF THIS INFORMATION, THE FOLLOWING WAS CONCLUDED: THE COMPLAINT OF A LEAKING CATHETER WAS UNCONFIRMED BECAUSE THE PROBLEM COULD NOT BE REPRODUCED. THE PRODUCT RETURNED FOR EVALUATION WAS ONE 5FR D/L POWERPICC CATHETER. USAGE RESIDUES WERE OBSERVED THROUGHOUT THE SAMPLE AND NEEDLELESS INJECTION CAPS WERE ATTACHED TO THE LUER ADAPTERS. MICROSCOPIC INSPECTION OF THE SAMPLE DID NOT REVEAL ANY DAMAGE OR EVIDENCE OF LEAKAGE. AN ATTEMPT TO INFUSE WATER THROUGH THE SAMPLE USING A 12ML SYRINGE REVEALED BOTH LUMENS TO BE PATENT TO INFUSION AND ASPIRATION WITH NO OBSERVED LEAKS. NO LEAKS WERE OBSERVED DURING SUSTAINED (>15 SECONDS) PRESSURIZATION. NO DEFICIENCIES WERE DISCOVERED DURING EVALUATION OF THE RETURNED SAMPLE. CONSEQUENTLY THIS COMPLAINT IS UNCONFIRMED AT THIS TIME. H3 OTHER TEXT : EVALUATION FINDINGS ARE IN SECTION H.11.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT LEAKING FROM PICC SITE NOTED ON DAY 2 OF INFUSIONS. PICC INSERTED (B)(6) 2022. NIL COMPLICATIONS ON INSERTION. ECG WAVES CLEAR AND CONCISE. CXR CONFIRMED PLACEMENT AT CAJ. CATHETER TRIMMED TO 47CM EXTERNAL LENGTH 4CM. PICC REMOVED ON DAY 3.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT LEAKING FROM PICC SITE NOTED ON DAY 2 OF INFUSIONS. PICC INSERTED (B)(6)2022. NIL COMPLICATIONS ON INSERTION. ECG WAVES CLEAR AND CONCISE. CXR CONFIRMED PLACEMENT AT CAJ. CATHETER TRIMMED TO 47CM EXTERNAL LENGTH 4CM. PICC REMOVED ON DAY 3.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313666 PPICC 5FR,D/L, 3CG CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS LJS C.R. BARD, INC. (BASD) -3006260740 N/A REFY3640

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other