BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONNECTA PLUS3 WHITE PEGS

    MDR report key: 8833449 · Received July 26, 2019

    Report

    Report Number
    2243072-2019-01510
    Event Type
    Malfunction
    Date Received
    July 26, 2019
    Date of Event
    June 21, 2019
    Report Date
    August 16, 2019
    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
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE EVENT DESCRIPTION, MEDICAL DEVICE BRAND NAME, COMMON DEVICE NAME, MEDICAL DEVICE TYPE, DEVICE MANUFACTURER, DEVICE EXPIRATION DATE, DEVICE MANUFACTURE DATE, UNIQUE IDENTIFIER NUMBER, PMA/510(K)#, AND DEVICE MANUFACTURE DATE HAVE BEEN UPDATED.THE FOLLOWING INFORMATION HAS BEEN UPDATED: B.5. DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THAT THE CONNECTA PLUS3 WHITE PEG EXPERIENCED LEAKAGE/DAMAGE/DEFORMATION WHICH WAS NOTED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ONE CONNECTA WAS NOTICED WITH CRACKED SEVERAL HOURS AFTER START USAGE NO INJURY TO THE PATIENT D.1. MEDICAL DEVICE BRAND NAME: CONNECTA PLUS3 WHITE PEGS; D.1. COMMON DEVICE NAME: STOP COCK; D.2. MEDICAL DEVICE TYPE: FMG; D.4. MEDICAL DEVICE CATALOG #: 394601; D.4. MEDICAL DEVICE LOT #: 8122914; D.3. MEDICAL DEVICE MANUFACTURER: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V., NOGALES; D.4. MEDICAL DEVICE EXPIRATION DATE: 2021-04-30; D.4. UNIQUE IDENTIFIER (UDI) #: (B)(4); G.1. MANUFACTURING LOCATION: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V., NOGALES; G.5. PMA/510(K)#: N/A; H.4. DEVICE MANUFACTURE DATE: 2018-06-27; H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CONNECTA PLUS3 WHITE PEG EXPERIENCED LEAKAGE/DAMAGE/DEFORMATION WHICH WAS NOTED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ONE CONNECTA WAS NOTICED WITH CRACKED SEVERAL HOURS AFTER START USAGE; NO INJURY TO THE PATIENT.

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: SINCE A LOT NUMBER COULD NOT BE CONNECTED TO THE DEVICE IDENTIFIED IN THE COMPLAINT, BD INVESTIGATORS COULD NOT CONDUCT A DEVICE HISTORY REVIEW FOR THIS EVENT. ADDITIONALLY, A SAMPLE HAS NOT YET BEEN SUBMITTED FOR EVALUATION AND TESTING, PREVENTING BD ENGINEERS FROM CONDUCTING A FULL INVESTIGATION AND DETERMINING A ROOT CAUSE OF THE FAILURE MODE IDENTIFIED IN YOUR DESCRIPTION OF THE EVENT. UNKNOWN MANUFACTURER: THERE ARE MULTIPLE BD LOCATIONS WHERE THIS UNSPECIFIED BD DEVICE MAY HAVE BEEN MANUFACTURED. A CATALOG AND LOT NUMBER COULD NOT BE CONFIRMED FOR THIS INCIDENT AND WITHOUT THIS INFORMATION WE ARE UNABLE TO DETERMINE WHERE THE DEVICE WAS MANUFACTURED. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE UNSPECIFIED BD CATHETER EXPERIENCED LEAKAGE/DAMAGE/DEFORMATION WHICH WAS NOTED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ONE CONNECTA WAS NOTICED WITH CRACK SEVERAL HOURS AFTER START USAGE. NO INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    624212 CONNECTA PLUS3 WHITE PEGS STOP COCK FMG BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 8122914

    Patients

    Seq Age Sex Outcome Treatment
    1 Other