BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD CONNECTA¿ STOPCOCK 3-WAY

    MDR report key: 17375406 · Received July 22, 2023

    Report

    Report Number
    9610847-2023-00188
    Event Type
    Malfunction
    Date Received
    July 22, 2023
    Date of Event
    June 29, 2023
    Report Date
    July 28, 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
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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

    H6: INVESTIGATION SUMMARY: IT WAS REPORTED THE INCORRECT LABELING WAS ON THE PRODUCT. TO AID IN THE INVESTIGATION, ONE PHOTO WAS PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. THE REPORT OF THE LABELING OF A 3-WAY PRODUCT AND MENTIONED IN THE 4-WAY DOCUMENTATION. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 39500, LOT 2230119. 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) OR CAPAS. 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. MAINTENANCE RECORDS WERE EVALUATED, AND NO PROBLEMS WERE FOUND. A DEVIATION WAS OPENED TO EXPLAIN THE DEFECT AND THE TEAM IS WORKING ON A PROJECT TO SOLVE THE ISSUE. BASED ON THE INVESTIGATION, BD WAS ABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD CONNECTA¿ STOPCOCK 3-WAY EXPERIENCED INCORRECT LABEL INFORMATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: (B)(6) HAS RECEIVED RECENTLY CONNCETA 3 WAYS STOPCOKS. (B)(6) HAS NOTICED WRONG ITEM DISCRIPTION ON THE BOX OF CAT # 395000 AS "FOUR WAY STOPCOCK WITHOUT EXTENSION TUBE".

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD CONNECTA¿ STOPCOCK 3-WAY EXPERIENCED INCORRECT LABEL INFORMATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: (B)(6) HAS RECEIVED RECENTLY CONNECTA 3 WAYS STOPCOCKS. (B)(6) HAS NOTICED WRONG ITEM DESCRIPTION ON THE BOX OF CAT # 395000 AS "FOUR WAY STOPCOCK WITHOUT EXTENSION TUBE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2147370 BD CONNECTA¿ STOPCOCK 3-WAY STOPCOCK FMG BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 2230119

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown