BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEXIVA¿ CLOSED IV CATHETER SYSTEM

    MDR report key: 8019762 · Received October 30, 2018

    Report

    Report Number
    1710034-2018-00771
    Event Type
    Malfunction
    Date Received
    October 30, 2018
    Date of Event
    October 10, 2018
    Report Date
    January 8, 2019
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903835317
    PMA / PMN Number
    K161777
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT # 8123701. RECEIVED A Q-SYTE ASSEMBLY ALONG WITH A TOP WEB PAPER (PACKAGING) FROM A BD NEXIVA 24GA LOT NUMBER 8123701. VISUAL/MICROSCOPIC EVALUATION: THE NEXIVA ASSEMBLY WAS NOT RETURNED FOR EVALUATION. DAMAGE (TEAR) WAS OBSERVED ON THE SLIT OF THE SEPTUM TOP DISK. NO DAMAGE WAS OBSERVED ON THE COLUMN WALL OR ON ANY OF THE POLYCARBONATE MATERIAL. WATER LEAK TEST: NO LEAKAGE WAS OBSERVED WHEN THE UNIT WAS TESTED ON THE UN-ACTUATED POSITION. NO LEAKAGE WAS OBSERVED WHEN THE UNIT WAS TESTED ON THE ACTUATED POSITION. REVIEW OF THE PHOTOS AND VIDEO: THE PICTURES REVEALED EVIDENCE OF BLOOD SPLASH-SPILL. THE VIDEO DISPLAYS A Q-SYTE UNIT CONNECTED TO A PORT OF A NEXIVA UNIT. CLEAR LIQUID SPILL/LEAK COULD BE DETECTED COMING OUT FROM THE TOP OF THE Q-SYTE. CONCLUSION: INDETERMINATE- A DEFINITE SOURCE THAT CAUSED THE Q-SYTE UNIT TO LEAK (AT USER SETTING) COULD NOT BE DETERMINED. THE FAILURE MODE NORMALLY ATTRIBUTED TO THIS TYPE OF DEFECT ARE: INCORRECT INSERTION, EXCESSIVE ACTUATIONS OR FAILURE TO PROPERLY FLUSH THE DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A BD NEXIVA¿ CLOSED IV CATHETER SYSTEM HAD LEAKAGE AT THE Q-SYTE ON Y-SITE AND SQUIRTED FAR. THERE WAS NO REPORT OF EXPOSURE TO THE MUCOSAL MEMBRANE, SERIOUS INJURY, OR MEDICAL INTERVENTION.

    Additional Manufacturer Narrative · 1

    (B)(6). 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 A BD NEXIVA¿ CLOSED IV CATHETER SYSTEM HAD LEAKAGE AT THE Q-SYTE ON Y-SITE AND SQUIRTED FAR. THERE WAS NO REPORT OF EXPOSURE TO THE MUCOSAL MEMBRANE, SERIOUS INJURY, OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    860623 BD NEXIVA¿ CLOSED IV CATHETER SYSTEM IV CATHETER SYSTEM FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 8123701 00382903835317

    Patients

    Seq Age Sex Outcome Treatment
    1 Other