BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD CONNECTA STOPCOCK

    MDR report key: 10299919 · Received July 20, 2020

    Report

    Report Number
    9610847-2020-00215
    Event Type
    Malfunction
    Date Received
    July 20, 2020
    Date of Event
    June 29, 2020
    Report Date
    July 27, 2020
    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
    ID
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6. INVESTIGATION: A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR PROVIDED LOT NUMBERS 9122579, 9143770, AND 9277396. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS REPORTED INCIDENT AND ALL INSPECTIONS WERE FOUND TO BE WITHIN SPECIFICATION. TO AID IN THE INVESTIGATION OF THIS ISSUE, ONE VIDEO SAMPLE WAS RETURNED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. THROUGH EXAMINATION OF THE VIDEO SAMPLE, LEAKAGE WAS OBSERVED. THE MANUFACTURING EQUIPMENT WAS INSPECTED FOR SIGNS OF SHARP COMPONENTS THAT COULD HAVE CONTRIBUTED TO CUTS AND LEAKAGE, HOWEVER, NO SIGNS WERE FOUND. AT THIS TIME, A MANUFACTURING RELATED CAUSE COULD NOT BE DETERMINED FOR THIS INCIDENT. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD CONNECTA¿ STOPCOCK LEAKED DURING USE. LOT#'S 9122579, 9143770, AND 9277396 WERE REPORTED TO HAVE BEEN INVOLVED IN THIS EVENT, ALL WITH 1 OCCURRENCE EACH. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "LEAKAGE FROM EXT. SET OF CONNECTA" "THE NURSE REALIZED LEAKAGE FROM EXTENSION SET CONNECTA AFTER IT WAS ATTACHED TO THE INFUSION LINE WHERE THE FLUID COMING DOWN FROM THE BOTTLE TO THE INSERTION SITE (PERIPHERAL VEIN) AND LEAKED FROM THE SO-CALLED PIN HOLE IN THE EXTENSION LINE OF CONNECTA."

    Additional Manufacturer Narrative · 1

    THE REPORTED LOT # 9277396 WAS NOT FOUND FOR THE REPORTED CATALOG # 394995. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 9122579, MEDICAL DEVICE EXPIRATION DATE: 2022-04-30, DEVICE MANUFACTURE DATE: 2019-05-14, MEDICAL DEVICE LOT #: 9143770, MEDICAL DEVICE EXPIRATION DATE: 2022-04-30, DEVICE MANUFACTURE DATE: 2019-06-05. 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 LEAKED DURING USE. LOT#'S 9122579, 9143770, AND 9277396 WERE REPORTED TO HAVE BEEN INVOLVED IN THIS EVENT, ALL WITH 1 OCCURRENCE EACH. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "LEAKAGE FROM EXT. SET OF CONNECTA" "THE NURSE REALIZED LEAKAGE FROM EXTENSION SET CONNECTA AFTER IT WAS ATTACHED TO THE INFUSION LINE WHERE THE FLUID COMING DOWN FROM THE BOTTLE TO THE INSERTION SITE (PERIPHERAL VEIN) AND LEAKED FROM THE SO-CALLED PIN HOLE IN THE EXTENSION LINE OF CONNECTA."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    758112 BD CONNECTA STOPCOCK STOPCOCK FMG BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. SEE SECTION H.10.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other