BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONNECTA WHT 360DEG TB 25CM

    MDR report key: 11382512 · Received February 25, 2021

    Report

    Report Number
    9610847-2021-00084
    Event Type
    Malfunction
    Date Received
    February 25, 2021
    Date of Event
    February 2, 2021
    Report Date
    March 30, 2021
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FPA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: A COMPLAINT OF TUBING BURSTING OPEN WAS RECEIVED FROM THE CUSTOMER. 41 SAMPLES WERE RETURNED FOR INVESTIGATION. THROUGH TESTING, THE CUSTOMER COMPLAINT WAS VERIFIED. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED LOT NUMBER 0183678. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. THE ROOT CAUSE FOR THIS DEFECT WAS DETERMINED TO BE A MISALIGNMENT ISSUE DURING THE ASSEMBLY PROCESS OF THE TUBE AND THE FITTING. THIS IS THE FIRST COMPLAINT FOR TUBING DEFECTIVE/DAMAGED ON MATERIAL 394926 & BATCH 0183678.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT CONNECTA WHT 360DEG TB 25CM TUBING RUPTURED. THIS OCCURRED ON 3 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MEDICATION USED WITH THE PRODUCT? OMNIPAQUE. LEAKAGE? YES, LARGE AMOUNT OF CONTRAST AGENT ON PATIENT, EXAMINATION TABLE AND FLOOR. IMPACT ON A PATIENT? CONTRAST EXAMINATION ON CT - PATIENT HAS HAD LESS CONTRAST THAN NECESSARY DURING THE EXAMINATION. SAMPLES? UNUSED SAMPLE CAN BE SENT FOR INVESTIGATION. WE HAVE HAD THE PROBLEM WITH SOME STOPCOCKS. THE TUBING BURST OPEN DURING INJECTION AT THE LEVEL OF THE STOPCOCK.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 CONNECT A WHT 360DEG TB 25CM TUBING RUPTURED. THIS OCCURRED ON 3 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MEDICATION USED WITH THE PRODUCT? OMNIPAQUE. LEAKAGE? YES, LARGE AMOUNT OF CONTRAST AGENT ON PATIENT, EXAMINATION TABLE AND FLOOR. IMPACT ON A PATIENT? CONTRAST EXAMINATION ON CT - PATIENT HAS HAD LESS CONTRAST THAN NECESSARY DURING THE EXAMINATION. SAMPLES? UNUSED SAMPLE CAN BE SENT FOR INVESTIGATION. WE HAVE HAD THE PROBLEM WITH SOME STOPCOCKS. THE TUBING BURST OPEN DURING INJECTION AT THE LEVEL OF THE STOPCOCK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    279443 CONNECTA WHT 360DEG TB 25CM INTRAVASCULAR ADMINISTRATION SET FPA BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 0183678

    Patients

    Seq Age Sex Outcome Treatment
    1