BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD CONNECTA¿ STOPCOCK

    MDR report key: 9539374 · Received January 2, 2020

    Report

    Report Number
    9610847-2019-00788
    Event Type
    Malfunction
    Date Received
    January 2, 2020
    Date of Event
    December 13, 2019
    Report Date
    February 14, 2020
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FMG
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR PROVIDED LOT NUMBERS 9213267 AND 9122579. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION PROCESS OF EITHER LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THIS REPORTED INCIDENT. TO FURTHER INVESTIGATE THIS INCIDENT, TWO SAMPLES BELONGING TO LOT NUMBER 9213267 WERE RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. PICTURE SAMPLES WERE ALSO PROVIDED. THROUGH EXAMINATION OF THE PROVIDED SAMPLES, DAMAGE WAS OBSERVED TO THE EXTENSION TUBING. THIS TUBING DAMAGE WAS DETERMINED TO BE THE CAUSE OF THE LEAKAGE. OUR QUALITY TEAM WAS UNABLE TO IDENTIFY A LOCATION IN THE MANUFACTURING PROCESS THAT COULD HAVE CAUSED THE OBSERVED TUBING DAMAGE. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT LEAKAGE OCCURRED DURING ADMINISTRATION OF MEDICATION WITH A BD CONNECTA¿ STOPCOCK. THIS OCCURRED ON 3 SEPARATE OCCASIONS DURING USE, HOWEVER, THE DATE/TIME AND OR PATIENT INFORMATION IS UNKNOWN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM GERMAN TO ENGLISH: THE 3-WAY-STOPCOCK WAS CONNECTED APPROPRIATELY. WHEN THE INFUSION RAN, A LEAKAGE IN THE LINE WAS NOTICED. THE INFUSION SOLUTION LEAKED. AT THAT MOMENT, PROPOFOL WAS BEING ADMINISTERED.

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER PHONE #: UNKNOWN. A SAMPLE IS AVAILABLE FOR EVALUATION. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT LEAKAGE OCCURRED DURING ADMINISTRATION OF MEDICATION WITH A BD CONNECTA¿ STOPCOCK. THIS OCCURRED ON 3 SEPARATE OCCASIONS DURING USE, HOWEVER, THE DATE/TIME AND OR PATIENT INFORMATION IS UNKNOWN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: THE 3-WAY-STOPCOCK WAS CONNECTED APPROPRIATELY. WHEN THE INFUSION RAN, A LEAKAGE IN THE LINE WAS NOTICED. THE INFUSION SOLUTION LEAKED. AT THAT MOMENT, PROPOFOL WAS BEING ADMINISTERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    4790 BD CONNECTA¿ STOPCOCK STOPCOCK FMG BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 9122579

    Patients

    Seq Age Sex Outcome Treatment
    1 Other