BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONNECTA PLUS3 WHITE

    MDR report key: 10411644 · Received August 14, 2020

    Report

    Report Number
    9610847-2020-00244
    Event Type
    Malfunction
    Date Received
    August 14, 2020
    Date of Event
    July 21, 2020
    Report Date
    September 9, 2020
    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
    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 0031061 AND THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS REPORTED INCIDENT. TO AID IN THE INVESTIGATION OF THIS ISSUE, BOTH PICTURE SAMPLES AND REPRESENTATIVE PHYSICAL SAMPLES WERE RETURNED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. THE SAMPLES WERE FUNCTIONALLY INSPECTED THROUGH THE USE OF CONNECTION AND LEAKAGE TESTING; HOWEVER, NO SIGNS OF LEAKAGE, DISCONNECTION, OR SEPARATION WERE DETECTED. BASED ON THE INVESTIGATION RESULTS, AN EXACT MANUFACTURING RELATED CAUSE COULD NOT BE DETERMINED FOR THIS INCIDENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT CONNECTA PLUS3 WHITE CAP WOULD DISCONNECT AND LEAK. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CAPS, CONNECTED TO THE BD VENFLON PRO SAFETY OR NFC CATHETERS FROM ICU CLAVE CONNECTOR, LEAK OR DISCONNECT EASILY. THE ROTATING RING ON THE MALE CONNECTION, WHICH IS DIFFICULT TO ROTATE WHEN CONNECTING TO THE CATHETER HUB, ACCIDENTALLY DISENGAGES DURING USE, COMPROMISING THE GOOD TIGHTNESS OF THE CONNECTION AND LEAKING BLOOD, INFUSION SOLUTIONS AND ANALGESIC DRUGS. SPECIFICALLY FOR THE MOST RELEVANT EVENT, THE TAP WAS CONNECTED TO A BD VENFLON PRO SAFETY 18 G CATHETER TO WHICH TWO INFUSIONS WERE CONNECTED: REHYDRATION THERAPY AND CAD PUMP INFUSION LINE WITH ANALGESIC THERAPY. DURING THE NIGHT THE PATIENT WOKE UP AND REPORTED THE PRESENCE OF BLOOD ON THE SHEET DUE TO THE TOTAL DISCONNECTION OF THE TAP FROM THE CATHETER.

    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT CONNECTA PLUS3 WHITE CAP WOULD DISCONNECT AND LEAK. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CAPS, CONNECTED TO THE BD VENFLON PRO SAFETY OR NFC CATHETERS FROM ICU CLAVE CONNECTOR, LEAK OR DISCONNECT EASILY. THE ROTATING RING ON THE MALE CONNECTION, WHICH IS DIFFICULT TO ROTATE WHEN CONNECTING TO THE CATHETER HUB, ACCIDENTALLY DISENGAGES DURING USE, COMPROMISING THE GOOD TIGHTNESS OF THE CONNECTION AND LEAKING BLOOD, INFUSION SOLUTIONS AND ANALGESIC DRUGS. SPECIFICALLY FOR THE MOST RELEVANT EVENT, THE TAP WAS CONNECTED TO A BD VENFLON PRO SAFETY 18 G CATHETER TO WHICH TWO INFUSIONS WERE CONNECTED: REHYDRATION THERAPY AND CAD PUMP INFUSION LINE WITH ANALGESIC THERAPY. DURING THE NIGHT THE PATIENT WOKE UP AND REPORTED THE PRESENCE OF BLOOD ON THE SHEET DUE TO THE TOTAL DISCONNECTION OF THE TAP FROM THE CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    870249 CONNECTA PLUS3 WHITE CATHETER FPA BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 0031061

    Patients

    Seq Age Sex Outcome Treatment
    1 Other