BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNSPECIFIED BD¿ CATHETER

    MDR report key: 9536506 · Received December 31, 2019

    Report

    Report Number
    2243072-2019-02928
    Event Type
    Malfunction
    Date Received
    December 31, 2019
    Date of Event
    December 9, 2019
    Report Date
    February 11, 2020
    Manufacturer
    BECTON DICKINSON
    Product Code
    FOZ
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: OUR QUALITY ENGINEER INSPECTED THE SAMPLE AND PHOTOGRAPH SUBMITTED FOR EVALUATION. BD RECEIVED THE 22GA NEXIVA IV CATHETER SYSTEM UNIT WITHOUT PACKAGING. THE UNIT CONSISTED OF THE CATHETER/ADAPTER ASSEMBLY WITH THE EXTENSION TUBING ATTACHED. THERE MEDIA PRESENT WITHIN THE LENGTH OF THE CATHETER TUBING AND SLIGHT TRACES IN THE EXTENSION TUBING. THE PHOTOGRAPH PROVIDED DISPLAYED SIMILARITIES TO THAT OF THE RETURNED UNIT. THROUGH THE VISUAL MICROSCOPIC EVALUATION OF THE UNIT, THE EXTENSION TUBING DEMONSTRATED TO BE SEPARATED FROM THE AREA NEAR/IN THE NOSE OF THE LUER ADAPTER. THE WALLS OF THE TUBING IN THE AREA OF SEPARATION WERE SHOWN TO BE ROUGH AND JAGGED WHICH IS INDICATIVE OF A BREAK BY STRESS. BASED ON THE FINDINGS FROM OUR INVESTIGATION, THE UNIT DEMONSTRATED SEPARATION BY STRESS, WHICH WAS INDICATION THAT THE TUBING WAS BROKEN, THUS RESULTING IN SEPARATION. THERE WAS NO PHYSICAL EVIDENCE TO CONFIRM OR SUPPORT MANUFACTURING PROCESS RELATED ISSUE FOR THE REPORTED DEFECT. PER THE VERBIAGE IN THE INITIAL REPORT, THERE IS EVIDENCE THAT THE EXTENSION TUBING WAS INADVERTENTLY BROKEN BY THE USER/PATIENT. A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED AS THE LOT NUMBER IS UNKNOWN. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED THAT THE UNSPECIFIED BD¿ CATHETER HAS BEEN FOUND EXPERIENCING SEPARATION OF THE TUBING FROM THE ADAPTER AFTER USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: THE BD NEXIVA WAS PLACED ON PATIENT AND PROVIDED WITH AN EXTENSION. THE PATIENT STEPPED ON THIS EXTENSION AND THE ENTIRE LINE HAS COME UNDER TENSION. THE EXTENSION PIECE ON THE NEXIVA TUBE HAS BEEN TORN OFF. THE NEXIVA HAD TO BE REMOVED.

    Additional Manufacturer Narrative · 1

    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. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT THE UNSPECIFIED BD¿ CATHETER HAS BEEN FOUND EXPERIENCING SEPARATION OF THE TUBING FROM THE ADAPTER AFTER USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: THE BD NEXIVA WAS PLACED ON PATIENT AND PROVIDED WITH AN EXTENSION. THE PATIENT STEPPED ON THIS EXTENSION AND THE ENTIRE LINE HAS COME UNDER TENSION. THE EXTENSION PIECE ON THE NEXIVA TUBE HAS BEEN TORN OFF. THE NEXIVA HAD TO BE REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1331691 UNSPECIFIED BD¿ CATHETER CATHETER FOZ BECTON DICKINSON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 24 MO Other