BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD CONNECTA¿

    MDR report key: 16725532 · Received April 12, 2023

    Report

    Report Number
    9610847-2023-00084
    Event Type
    Malfunction
    Date Received
    April 12, 2023
    Date of Event
    March 14, 2023
    Report Date
    April 19, 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

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL: YES. D10: RETURNED TO MANUFACTURER ON: 24-APR-2023. H6: INVESTIGATION SUMMARY: OUR QUALITY ENGINEER INSPECTED THE 2 PHOTOS, 7 UNOPENED SAMPLES AND 9 OPENED SAMPLES SUBMITTED FOR EVALUATION. THE REPORTED ISSUE OF ADAPTER/CONNECTOR DEFECTIVE/DAMAGED WAS NOT CONFIRMED UPON INSPECTION AND TESTING OF THE SAMPLES. ANALYSIS OF THE SAMPLES SHOWED THAT THERE WERE NO VISIBLE DAMAGES OR DEFECTS ON THE RETURNED SAMPLES. EACH SAMPLE WAS FUNCTIONALLY TESTED AND NONE OF THE SAMPLES SHOWED ANY CONNECTION ISSUES. BD WAS UNABLE TO DETERMINE A ROOT CAUSE FOR THE FAILURE SINCE THE DEFECT WAS NOT CONFIRMED DURING THE SAMPLE EVALUATIONS. IT IS RECOMMENDED THAT PRIOR TO THE USE OF BD PRODUCTS TO REVIEW THE INSTRUCTIONS FOR USE DOCUMENTATION SUPPLIED TO ENSURE THE GREATEST CHANCES OF THERE BEING NO FAILURES DURING USE. PRODUCTION RECORDS WERE REVIEWED, AND THESE BATCHES MET OUR MANUFACTURING PRODUCT SPECIFICATION REQUIREMENTS.

    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. MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH ADDITIONAL LOT NUMBER IS AS FOLLOWS: D.4. MEDICAL DEVICE LOT #: 2152126. D.4. MEDICAL DEVICE EXPIRATION DATE: 31-MAY-2025. H.4. DEVICE MANUFACTURE DATE: 15-JUN-2022. D.4. MEDICAL DEVICE LOT #: 2153875 . D.4. MEDICAL DEVICE EXPIRATION DATE: 31-MAY-2025. H.4. DEVICE MANUFACTURE DATE: 21-JUN-2022. D.4. MEDICAL DEVICE LOT #: 2153877. D.4. MEDICAL DEVICE EXPIRATION DATE: 31-MAY-2025. H.4. DEVICE MANUFACTURE DATE: 27-JUN-2022.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD CONNECTA¿ DID NOT CONNECT WELL HAVE WITHDRAWN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM SPANISH TO ENGLISH: BD CONNECTA¿ KEY WITH 25 CM EXTENSION CORD -THE LUER-LOK EXTENSION CORD TERMINATION IS WRONG AND DOES NOT CONNECT PROPERLY. BEFORE USING THE PRODUCT HAVE REALIZED THAT COMES WRONG CONNECTION LUER-LOK EXTENSION AND DOES NOT CONNECT WELL HAVE WITHDRAWN THE PRODUCT TO NOT USE THE AFFECTED BATCH.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD CONNECTA¿ DID NOT CONNECT WELL HAVE WITHDRAWN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM SPANISH TO ENGLISH: BD CONNECTA¿ KEY WITH 25 CM EXTENSION CORD THE LUER LOK EXTENSION CORD TERMINATION IS WRONG AND DOES NOT CONNECT PROPERLY. BEFORE USING THE PRODUCT HAVE REALIZED THAT COMES WRONG CONNECTION LUER LOK EXTENSION AND DOES NOT CONNECT WELL HAVE WITHDRAWN THE PRODUCT TO NOT USE THE AFFECTED BATCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1007940 BD CONNECTA¿ INTRAVASCULAR ADMINISTRATION SET FPA BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown