BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONNECTA WHT 360DEG TB 25CM

    MDR report key: 9963052 · Received April 15, 2020

    Report

    Report Number
    9610847-2020-00135
    Event Type
    Malfunction
    Date Received
    April 15, 2020
    Date of Event
    March 17, 2020
    Report Date
    July 31, 2020
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FMG
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVALUATION?: YES. D.10. RETURNED TO MANUFACTURER ON: (B)(6)2020. H.6. INVESTIGATION: A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR PROVIDED LOT NUMBER 9193077. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS REPORTED INCIDENT AND ALL INSPECTIONS WERE FOUND TO BE WITHIN SPECIFICATION. TO AID IN THE INVESTIGATION OF THIS INCIDENT, ONE PHYSICAL SAMPLE WAS RETURNED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. THROUGH EXAMINATION OF THE SAMPLE, THE ADAPTER COMPONENT WAS OBSERVED SEPARATED FROM THE TUBING. IT HAS BEEN DETERMINED THAT THIS SEPARATION WAS A RESULT OF PARTIAL ADHESIVE SOLVENT BETWEEN THE TWO COMPONENTS, WHICH WOULD ALSO RESULT IN LEAKAGE. A QUALITY ALERT HAS BEEN RAISED IN RESPONSE TO THIS INCIDENT.

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED LOT NUMBER 9193077. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF CONNECTAS WHT 360DEG TB 25CM EXPERIENCED TUBING SEPARATION FROM ADAPTER/LUER CONNECTION. PRODUCT DEFECT WAS NOTED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: EACH TIME YOU FLUSH THE ACCESS FROM THE EXTENSION CORD, IT DISCONNECTS FROM THE PROXIMAL CONNECTION TO THE VENOUS ACCESS. LEAKAGE OF THE INFUSION WITH DISPERSION AND CONTAMINATION OF THE DRUG.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF CONNECTAS WHT 360DEG TB 25CM EXPERIENCED TUBING SEPARATION FROM ADAPTER/LUER CONNECTION. PRODUCT DEFECT WAS NOTED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: EACH TIME YOU FLUSH THE ACCESS FROM THE EXTENSION CORD, IT DISCONNECTS FROM THE PROXIMAL CONNECTION TO THE VENOUS ACCESS. LEAKAGE OF THE INFUSION WITH DISPERSION AND CONTAMINATION OF THE DRUG.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF CONNECTAS WHT 360DEG TB 25CM EXPERIENCED TUBING SEPARATION FROM ADAPTER/LUER CONNECTION. PRODUCT DEFECT WAS NOTED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: EACH TIME YOU FLUSH THE ACCESS FROM THE EXTENSION CORD, IT DISCONNECTS FROM THE PROXIMAL CONNECTION TO THE VENOUS ACCESS. LEAKAGE OF THE INFUSION WITH DISPERSION AND CONTAMINATION OF THE DRUG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    429575 CONNECTA WHT 360DEG TB 25CM STOPCOCK FMG BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 9193077

    Patients

    Seq Age Sex Outcome Treatment
    1 Other