BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AS LVP 20D LOW SORB 2SS 0.2M CV

    MDR report key: 20799102 · Received November 27, 2024

    Report

    Report Number
    9616066-2024-01754
    Event Type
    Malfunction
    Date Received
    November 27, 2024
    Date of Event
    October 24, 2024
    Report Date
    January 14, 2025
    Manufacturer
    BECTON DICKINSON
    Product Code
    FPA
    UDI-DI
    10885403232343
    PMA / PMN Number
    K022209
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED BY THE CUSTOMER THAT INFUSION FLUID NOTED TO BE LEAKING FROM POINT OF CHEMO STAT LOCK. ONE SAMPLE OF ITEM NUMBER: 11532269 WAS RECEIVED ALONG WITH AN UNIDENTIFIED INFUSION SET WITH ICU MEDICAL CHEMOLOCK CONNECTOR. VISUAL EXAMINATION WAS CONDUCTED ON THE BD INFUSION SET ITEM: 11532269. THERE WERE NO DAMAGES OR ABNORMALITIES IDENTIFIED ON THE BD SET. THE BD SET WAS THEN PRIMED AND CHECKED FOR LEAKAGE, AIR-IN-LINE, AND OCCLUSION. THERE WERE NO ISSUES IDENTIFIED ON THE BD SET. A SIMULATED INFUSION WAS THEN CONDUCTED USING THE BD SET AND THERE WERE NO ISSUES DURING THE INFUSION. THE REPORTED LEAKAGE WAS NOT REPLICATED ON THE SAMPLE OF THE BD INFUSION SET THAT WAS PROVIDED. THE UNKNOWN SECONDARY SET WAS THEN CONNECTED TO THE BD INFUSION SET VIA THE ICU MEDICAL CONNECTOR. A LEAK WAS NOTICED THE CONNECTION POINT BETWEEN THE ICU MEDICAL CONNECTOR AND THE UNKNOWN EXTENSION SET, HOWEVER, THESE PRODUCTS ARE NOT BD PRODUCTS. A ROOT CAUSE WAS NOT DETERMINED BECAUSE THE FAILURE WAS NOT REPLICATED ON THE BD PRIMARY INFUSION SET.

    Additional Manufacturer Narrative · 0

    INITIAL MDR SUBMISSION. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED.

    Description of Event or Problem · 0

    MATERIAL#: 11532269, BATCH#: 24066671. IT WAS REPORTED BY THE CUSTOMER THAT INFUSION FLUID NOTED TO BE LEAKING FROM POINT OF CHEMO STAT LOCK. RCC RECEIVED A COMPLAINT VIA EMAIL. INFUSION FLUID NOTED TO BE LEAKING FROM POINT OF CHEMO STAT LOCK CAT# OF PRODUCT BEING COMPLAINED: AL11532269. DESCRIPTION OF PRODUCT: SET CHECK VALVE 0.2MIC 2NF 87/6IN 2PC MALE L/L 20EA/CA. ADDITIONAL INFO: IN ANSWER TO YOUR QUERIES: 1. NO ADVERSE EVENT REPORTED. 2. LOT#: (10) 24066671. 3. WE HAVE HAD TWO OCCURRENCES. 4. ON THIS OCCURRENCE THERE WAS NO CHEMOTHERAPY DRUG, HOWEVER ON THE FIRST OCCASION IT WAS. I WILL RETURN THE PRODUCT, WITH ATTACHED BAG OF FLUID (NON-CHEMOTHERAPY AGENT). ADDITIONAL INFO: I HAVE ASKED FOR THE PACKAGING TO BE SENT TO ME AT THE CORRECT ADDRESS AS IT WAS SENT TO THE PHARMACY DEPARTMENT AT VANCOUVER, DESPITE THE CORRECT ADDRESS BEING SENT FROM MYSELF IN ALL CORRESPONDENCE. THIS IS NOT AN ERROR ON MY PART AND I REQUEST, AGAIN, THAT PACKAGING IS SENT DIRECTLY TO ME AT THE ADDRESS BELOW.

    Description of Event or Problem · 0

    MATERIAL#: 11532269; BATCH#: UNKNOWN. IT WAS REPORTED BY THE CUSTOMER THAT INFUSION FLUID NOTED TO BE LEAKING FROM POINT OF CHEMO STAT LOCK. RCC RECEIVED A COMPLAINT VIA EMAIL. INFUSION FLUID NOTED TO BE LEAKING FROM POINT OF CHEMO STAT LOCK CAT# OF PRODUCT BEING COMPLAINED: AL11532269. DESCRIPTION OF PRODUCT: SET CHECK VALVE 0.2MIC 2NF 87/6IN 2PC MALE L/L 20EA/CA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    850782 AS LVP 20D LOW SORB 2SS 0.2M CV SET, ADMINISTRATION, INTRAVASCULAR FPA BECTON DICKINSON 24066671 10885403232343

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown