BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONNECTA PLUS3 WHITE PEGS

    MDR report key: 12060242 · Received June 24, 2021

    Report

    Report Number
    9610847-2021-00288
    Event Type
    Malfunction
    Date Received
    June 24, 2021
    Date of Event
    May 15, 2021
    Report Date
    June 29, 2021
    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
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED LOT NUMBER 394601. 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 AND THEREFOR THE FAILURE WAS NOT CONFIRMED. FOR FURTHER INVESTIGATIONS IT'S RECOMMENDED THAT THE INVOLVED SAMPLE BE PROVIDED FOR EVALUATION. THE APPEARANCE OF THESE CRACKS IS TYPICAL FOR CRACKS THAT CAN OCCUR WHEN THE PRODUCT HAS BEEN USED TOGETHER WITH LUBRICATION SOLUTION OR INFUSION WITH HIGH PH-VALUE. THESE SOLUTIONS CAN RELEASE INTERNAL STRESS IN THE PRODUCT. IF EXCESSIVE FORCE IS USED WHEN CONNECTING AND USING THE PRODUCT FOR MORE THAN 24 HOURS, THIS MAY CAUSE THE MATERIAL TO CRACK. CHC WAS PERFORMED. THIS IS THE FIRST COMPLAINT FOR LEAKAGE ON MATERIAL 394601 & BATCH 0184584. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT CONNECTA PLUS3 WHITE PEGS LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: (B)(6) 2021. THE NURSE USED THE CONNECTA IN COMBINATION WITH THE MICRO-INJECTION PUMP FOR DRUG INJECTION. THERE WAS NO LEAKAGE WHEN IT WAS FIRST CONNECTED, AND THERE WAS LEAKAGE AT THE CONNECTA AFTERWARDS, AND THERE WAS SLIGHT DAMAGE. IT WAS NOT FOUND AFTER REPLACING THE NEW ONE IMMEDIATELY. EXUDATE. THE INCIDENT DID NOT CAUSE HARM TO THE PATIENT. (B)(6) 2021 RECEIVED AN UPDATE FROM THE SALES REPRESENTATIVE. THE DESCRIPTION OF THE INCIDENT WAS UPDATED AS FOLLOWS: IT IS UNDERSTOOD THAT THE DEPARTMENT WHERE THE INCIDENT OCCURRED IS THE DEPARTMENT OF NEUROLOGY. THE NURSE USED THE CONNECTA IN COMBINATION WITH THE MICRO-INJECTION PUMP FOR DRUG INJECTION. THERE IS NO LEAKAGE WHEN IT IS FIRST CONNECTED, AND THERE IS LEAKAGE AT THE CONNECTA AFTERWARDS. THE LIQUID IS FROM THE SWITCH VALVE KNOB. IF THE PLACE LEAKED, IMMEDIATELY REPLACED WITH A NEW ONE, AND NO SEEPAGE WAS FOUND. THE INCIDENT DID NOT CAUSE HARM TO THE PATIENT.

    Additional Manufacturer Narrative · 1

    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 · 1

    IT WAS REPORTED THAT CONNECTA PLUS3 WHITE PEGS LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: (B)(6) 2021 THE NURSE USED THE CONNECTA IN COMBINATION WITH THE MICRO-INJECTION PUMP FOR DRUG INJECTION. THERE WAS NO LEAKAGE WHEN IT WAS FIRST CONNECTED, AND THERE WAS LEAKAGE AT THE CONNECTA AFTERWARDS, AND THERE WAS SLIGHT DAMAGE. IT WAS NOT FOUND AFTER REPLACING THE NEW ONE IMMEDIATELY. EXUDATE. THE INCIDENT DID NOT CAUSE HARM TO THE PATIENT. (B)(6) 2021 RECEIVED AN UPDATE FROM THE SALES REPRESENTATIVE. THE DESCRIPTION OF THE INCIDENT WAS UPDATED AS FOLLOWS: IT IS UNDERSTOOD THAT THE DEPARTMENT WHERE THE INCIDENT OCCURRED IS THE DEPARTMENT OF NEUROLOGY. THE NURSE USED THE CONNECTA IN COMBINATION WITH THE MICRO-INJECTION PUMP FOR DRUG INJECTION. THERE IS NO LEAKAGE WHEN IT IS FIRST CONNECTED, AND THERE IS LEAKAGE AT THE CONNECTA AFTERWARDS. THE LIQUID IS FROM THE SWITCH VALVE KNOB. IF THE PLACE LEAKED, IMMEDIATELY REPLACED WITH A NEW ONE, AND NO SEEPAGE WAS FOUND. THE INCIDENT DID NOT CAUSE HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    956393 CONNECTA PLUS3 WHITE PEGS INTRAVASCULAR ADMINISTRATION SET FPA BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 0184584

    Patients

    Seq Age Sex Outcome Treatment
    1