BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD CONNECTA¿ STOPCOCK WITH EXTENSION SET

    MDR report key: 17708909 · Received September 8, 2023

    Report

    Report Number
    9610847-2023-00252
    Event Type
    Malfunction
    Date Received
    September 8, 2023
    Date of Event
    August 14, 2023
    Report Date
    November 1, 2023
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FPA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED MATERIAL NUMBER 394926 AND LOT NUMBER 2182118. 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. AS A SAMPLE WAS UNAVAILABLE FOR RETURN, A THOROUGH SAMPLE INVESTIGATION COULD NOT BE COMPLETED. BASED ON THE INVESTIGATION RESULTS, AN EXACT CAUSE FOR THIS INCIDENT COULD NOT BE IDENTIFIED. SHOULD YOU AGAIN EXPERIENCE ANY PROBLEMS WITH OUR PRODUCT WE WOULD APPRECIATE THE OPPORTUNITY TO CONDUCT A THOROUGH ANALYSIS. THERE ARE QUALITY CONTROLS CURRENTLY IN PLACE TO DETECT THIS TYPE OF DEFECT DURING THE PRODUCTION PROCESS. FURTHER ACTION HAS NOT BEEN DETERMINED NECESSARY AT THIS TIME. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. OUR QUALITY TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. H3 OTHER TEXT : SEE NARRATIVE BELOW

    Additional Manufacturer Narrative · 0

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH ADDITIONAL LOT NUMBER IS AS FOLLOWS: D4. MEDICAL DEVICE LOT #: 2221474. D4. MEDICAL DEVICE EXPIRATION DATE: 31JUL2025. H4. DEVICE MANUFACTURE DATE: 26AUG2022. H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    DURING USE. FROM THE RADIOLOGY SERVICE OF HOSPITAL (B)(6), THEY INFORM US THAT THEY ARE HAVING PROBLEMS WITH REF (B)(4). WHEN ENTERING THE CONTRAST UNDER PRESSURE (CT), THE VALVE BREAKS, WHICH MEANS THAT THERE IS CONTRAST AND BLOOD ALL OVER. THE ONES THAT HAVE BEEN IDENTIFIED ARE BATCH 2221474 B, 2221474 C AND 2182118 A. I HAVE BEEN TOLD THAT IT HAS HAPPENED REPEATEDLY, INCLUDING 2 TIMES IN THIS LAST NIGHT SHIFT. AT THE MOMENT THEY HAVE REMOVED THE MATERIAL FROM THIS LOT.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD CONNECTA¿ STOPCOCK WITH EXTENSION SET THE PRODUCT WAS DAMAGED AND LEAKAGE OCCURRED. THIS OCCURRED 2 TIMES. THIS IS REPORT 1 OF 2. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM SPANISH TO ENGLISH: WHEN ENTERING THE CONTRAST UNDER PRESSURE (CT), THE VALVE BREAKS, WHICH MEANS THAT THERE IS CONTRAST AND BLOOD ALL OVER. THE ONES THAT HAVE BEEN IDENTIFIED ARE BATCH 2221474 B, 2221474 C AND 2182118 A. I HAVE BEEN TOLD THAT IT HAS HAPPENED REPEATEDLY, INCLUDING 2 TIMES IN THIS LAST NIGHT SHIFT. AT THE MOMENT THEY HAVE REMOVED THE MATERIAL FROM THIS LOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1502071 BD CONNECTA¿ STOPCOCK WITH EXTENSION SET INTRAVASCULAR ADMINISTRATION SET FPA BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 2182118

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown