BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD CONNECTA¿ PLUS STOPCOCK

    MDR report key: 17035351 · Received May 31, 2023

    Report

    Report Number
    9610847-2023-00132
    Event Type
    Malfunction
    Date Received
    May 31, 2023
    Date of Event
    May 9, 2023
    Report Date
    June 7, 2023
    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
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B.3. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. E.1 INITIAL REPORTER PHONE #: (B)(6). H3. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL? YES. D10: RETURNED TO MANUFACTURER ON: 25-MAY-2023. INVESTIGATION SUMMARY: IT WAS REPORTED THERE WAS BLACK FOREIGN MATTER. TO AID IN THE INVESTIGATION, ONE SAMPLE AND FIVE PHOTOS WERE PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. A VISUAL INSPECTION WAS PERFORMED AND THERE WAS FOREIGN MATERIAL FOUND IN THE COMPONENT TAP. THE FOREIGN MATTER IS RELATED TO THE MOLDING OF THE PART. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 394900, LOT 2223397. ACCORDING TO THE DOCUMENTED RECORDS, THE PRODUCT WAS MANUFACTURED ACCORDING TO THE APPROVED MANUFACTURING PROCEDURES, SPECIFICATIONS, AND THEN RELEASED BY QUALITY ASSURANCE. THERE WERE NO NONCONFORMANCE(S), CAPAS OR ABNORMAL CONDITIONS NOTED AT THE TIME OF PRODUCTION. AT THE TIME OF THE DHR REVIEW, THERE WERE NO CHANGES TO THE PROCESS AND/OR EQUIPMENT THAT WOULD HAVE AFFECTED THE MANUFACTURING OF THE DEVICE. TO DATE, THERE HAVE BEEN NO OTHER SIMILAR EVENTS REPORTED FOR THIS LOT. BASED ON THE INVESTIGATION, BD WAS ABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE OF FOREIGN MATTER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD CONNECTA¿ PLUS STOPCOCK EXPERIENCED FOREIGN MATTER, CONTAMINATED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: THE CUSTOMER REPORTED ABOUT BLACK FOREIGN MATTER FOUND UPON PACKAGE OPENING.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD CONNECTA¿ PLUS STOPCOCK EXPERIENCED FOREIGN MATTER, CONTAMINATED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: THE CUSTOMER REPORTED ABOUT BLACK FOREIGN MATTER FOUND UPON PACKAGE OPENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1837052 BD CONNECTA¿ PLUS STOPCOCK STOPCOCK FMG BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 2223397

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown