BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONNECTA WHT 360DEG TB 30CM

    MDR report key: 24927314 · Received April 20, 2026

    Report

    Report Number
    9610847-2026-00170
    Event Type
    Malfunction
    Date Received
    April 20, 2026
    Date of Event
    April 2, 2026
    Report Date
    April 20, 2026
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FMG
    PMA / PMN Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SPECIFICALLY, THE PROBLEM IS THAT OTHER TUBING FROM THE CONTRAST AGENT INJECTORS DOESN'T CONNECT WELL TO THIS BATCH OF TUBING BECAUSE THE CONNECTIONS ARE POOR. THIS HAS REPEATEDLY LED TO THE CONTRAST AGENT SQUIRTING OUT OF THE TUBING AT THE CONNECTION POINT AT HIGHER PRESSURES (> 2 ML/SECOND) (BOTH IN MRI AND CT SCANS). THIS NOT ONLY CREATES A MESS BUT ALSO DEGRADES IMAGE QUALITY. A COLLEAGUE REPORTED TO ME TODAY THAT DURING AN EXAMINATION, AIR EVEN ENTERED THE TUBING AND WAS INJECTED INTO THE PATIENT'S VEIN IN A SMALL AMOUNT. THE INJECTOR TUBING HAD BEEN PROPERLY VENTED. SHORT DESCRIPTION: LEAKING. WHEN DID THE INCIDENT OCCUR? DURING USE. MESSAGE FROM THE (B)(4) PHARMACY: "DEAR SIR OR MADAM, WE HAVE RECEIVED FEEDBACK FROM A CUSTOMER REGARDING YOUR DEVICE. APPARENTLY, THERE IS A CONNECTION OR SEALING PROBLEM WITH THE BD CONNECTA TUBES OF LOT 5213789 (EXP 31/07/2028). THE CUSTOMER CONCERNED HAS ALREADY BEEN ASKED TO RETURN THE GOODS IN QUESTION TO US FOR INSPECTION. WE WILL BE HAPPY TO FORWARD THE AFFECTED DEVICES TO YOU FOR FURTHER ANALYSIS. ACCORDING TO THE EMAIL MESSAGE BELOW, TWO INSTITUTES ARE AFFECTED AND PROBLEMS HAVE ARISEN SEVERAL TIMES IN RECENT WEEKS. THIS IS A PROBLEM FOR US, AS WE CURRENTLY HAVE THIS LOT IN STOCK AND HAVE ALREADY SUPPLIED SEVERAL CUSTOMERS WITH IT. NOTIFICATION OF THE (B)(4) CUSTOMER TO THE PHARMACY: "AS I HAVE JUST DISCUSSED WITH YOU BY TELEPHONE, I AM SENDING YOU A PICTURE OF THE AFFECTED TUBES WITH A THREE-WAY STOPCOCK. THE PROBLEM HAS ALREADY EXISTED FOR 2 TO 3 WEEKS IN INDIVIDUAL TESTS AT (B)(6) INSTITUTES. SPECIFICALLY, IT IS THE CASE THAT OTHER TUBES FROM THE CONTRAST MEDIUM INJECTORS ARE DIFFICULT TO CONNECT TO THIS LOT OF TUBES AS THEY DO NOT HOLD TOGETHER WELL. THIS HAS REPEATEDLY LED TO THE CONTRAST MEDIUM SQUIRTING OUT OF THE TUBE AT THE CONNECTION POINT AT HIGHER PRESSURES (> 2ML/SECOND) (BOTH IN MR AND CT). THIS NOT ONLY CREATES A ¿MESS¿ BUT ALSO AFFECTS THE IMAGE QUALITY. A COLLEAGUE TOLD ME TODAY THAT AIR EVEN ENTERED THROUGH THE TUBE DURING AN EXAMINATION AND WAS THUS INJECTED INTO THE PATIENT'S VEIN IN SMALL QUANTITIES. THE INJECTOR TUBE HAD BEEN PROPERLY VENTED. A PHARMACY IN SWITZERLAND HAS SENT US A COMPLAINT ABOUT BD CONNECTA 3-WAY STOPCOCKS WITH EXTENSION TUBE 25 CM OF LOT 5213789 (EXP 31/07/2028). SEE BELOW FOR THE WORDING OF THE MESSAGES. PLEASE LET US KNOW HOW WE SHOULD PROCEED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    984338 CONNECTA WHT 360DEG TB 30CM STOPCOCK, I.V. SET FMG BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 5213789

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown