BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD CONNECTA¿ STOPCOCK WITH EXTENSION SET

    MDR report key: 17708947 · Received September 8, 2023

    Report

    Report Number
    9610847-2023-00253
    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

    AS NO PHYSICAL SAMPLE, PICTURE SAMPLE, OR LOT NUMBER WAS PROVIDED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM, A COMPLETE INVESTIGATION COULD NOT BE PERFORMED. THERE ARE CURRENT QUALITY CONTROLS IN PLACE TO DETECT THIS TYPE OF PRODUCT MALFUNCTION DURING THE PRODUCTION PROCESS. BASED ON THE LIMITED INVESTIGATION RESULTS, A CAUSE FOR THE REPORTED INCIDENT COULD NOT BE DETERMINED. SHOULD YOU AGAIN EXPERIENCE ANY PROBLEMS WITH OUR PRODUCT WE WOULD APPRECIATE THE OPPORTUNITY TO CONDUCT A THOROUGH ANALYSIS. EXAMINATION OF THE PRODUCT INVOLVED MAY PROVIDE CLARIFICATION AS TO THE CAUSE FOR THE REPORTED FAILURE. 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.

    Additional Manufacturer Narrative · 0

    B.3. DATE OF EVENT IS UNKNOWN; AWARENESS DATE HAS BEEN USED FOR THIS FIELD. THERE WERE MULTIPLE POTENTIAL LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH ADDITIONAL LOT NUMBER IS AS FOLLOWS: D4. MEDICAL DEVICE LOT #: 2182118. D4. MEDICAL DEVICE EXPIRATION DATE: 30JUN2025. H4. DEVICE MANUFACTURE DATE: 19JUL2022. 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: 394926. 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 18 TIMES. THIS IS REPORT 2 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
    1243178 BD CONNECTA¿ STOPCOCK WITH EXTENSION SET INTRAVASCULAR ADMINISTRATION SET FPA BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown