BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD CONNECTA STOPCOCK

    MDR report key: 10908604 · Received November 26, 2020

    Report

    Report Number
    9610847-2020-00376
    Event Type
    Malfunction
    Date Received
    November 26, 2020
    Date of Event
    November 2, 2020
    Report Date
    February 10, 2021
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FMG
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 2020-12-22 H6: INVESTIGATION SUMMARY A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED LOT NUMBER 0062461. 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. TO AID IN THE INVESTIGATION OF THIS INCIDENT, PHYSICAL SAMPLES WERE RETURNED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. THROUGH EXAMINATION OF THE SAMPLES, DETACHMENT BETWEEN THE TUBE AND THE FITTING COMPONENT WAS IDENTIFIED. MAINTENANCE RECORDS WERE EVALUATED; HOWEVER, THERE WERE NO ANOMALIES IDENTIFIED THAT COULD HAVE RESULTED IN THIS DEFECT. SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD CONNECTA¿ STOPCOCK EXPERIENCED A LOOSE CONNECTION/SEPARATED/DETACHMENT WITH THE STOPCOCK/CAP. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER REPORTS: THE PATIENT WAS RECEIVING IV-CYTOSTATIC TREATMENT AND IN THE END OF THE TREATMENT WHEN FLUSHING WITH SALINE THE CONNECTA STOPCOCK EXTENSION TUBE CAME OF FROM THE PATIENTS IV CANNULA. THE TUBE WAS PUSHED BACK IN, BUT IMMEDIATELY FELL OF FROM LUER LOCK CONNECTION.

    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD CONNECTA¿ STOPCOCK EXPERIENCED A LOOSE CONNECTION/SEPARATED/DETACHMENT WITH THE STOPCOCK/CAP. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER REPORTS: THE PATIENT WAS RECEIVING IV-CYTOSTATIC TREATMENT AND IN THE END OF THE TREATMENT WHEN FLUSHING WITH SALINE THE CONNECTA STOPCOCK EXTENSION TUBE CAME OF FROM THE PATIENTS IV CANNULA. THE TUBE WAS PUSHED BACK IN, BUT IMMEDIATELY FELL OF FROM LUER LOCK CONNECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1377256 BD CONNECTA STOPCOCK STOPCOCK FMG BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 0062461

    Patients

    Seq Age Sex Outcome Treatment
    1