BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD CONNECTA STOPCOCK

    MDR report key: 11237514 · Received January 27, 2021

    Report

    Report Number
    9610847-2021-00040
    Event Type
    Malfunction
    Date Received
    January 27, 2021
    Date of Event
    January 5, 2021
    Report Date
    March 22, 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
    SW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVAL? YES. D.10. RETURNED TO MANUFACTURER ON: 3/8/2021. H.6. INVESTIGATION: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER: 0092636. 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 ISSUE, SAMPLES WERE RETURNED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. THE SAMPLES WERE INSPECTED AND TESTED FOR SIGNS OF LEAKAGE; HOWEVER, THE SAMPLES PERFORMED PER SPECIFICATION AND NO NEGATIVE RESULTS WERE FOUND.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD CONNECTA¿ STOPCOCK CONNECTION CAP FELL OFF WHEN OPENING THE PACKAGING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WHEN YOU OPEN THE PACKAGE, THE CAP THAT IS POSITION ON THE SIDE WHERE YOU CONNECT THE EXTRA SET FALLS OFF. THIS HAVE OCCURRED ON A NUMBER OF OCCASIONS DURING THE LAST TWO WEEKS."

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 CONNECTION CAP FELL OFF WHEN OPENING THE PACKAGING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WHEN YOU OPEN THE PACKAGE, THE CAP THAT IS POSITION ON THE SIDE WHERE YOU CONNECT THE EXTRA SET FALLS OFF. THIS HAVE OCCURRED ON A NUMBER OF OCCASIONS DURING THE LAST TWO WEEKS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136514 BD CONNECTA STOPCOCK STOPCOCK FMG BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 0092636

    Patients

    Seq Age Sex Outcome Treatment
    1