BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEXIVA DUAL PORT 20GA 1.00IN (1.1 MM X 25 MM)

    MDR report key: 9286541 · Received November 6, 2019

    Report

    Report Number
    1710034-2019-01188
    Event Type
    Malfunction
    Date Received
    November 6, 2019
    Date of Event
    October 22, 2019
    Report Date
    December 11, 2019
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903835362
    PMA / PMN Number
    K183399
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: THERE WAS NO SAMPLE OR PHOTO AVAILABLE TO BD FOR EVALUATION. THEREFORE, BD WAS UNABLE TO PERFORM A THOROUGH INVESTIGATION TO VERIFY THE REPORTED ISSUE. SINCE, AN INVESTIGATION COULD NOT BE PERFORMED BD WAS UNABLE TO DETERMINE A POSSIBLE ROOT CAUSE. LOT# IS UNKNOWN SO DHR CAN'T BE PERFORMED. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED THAT THE BD NEXIVA DUAL PORT 20GA 1.00IN (1.1 MM X 25 MM) HAS BEEN FOUND WITH DEFECTIVE TUBING DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 383536, BATCH NO: UNKNOWN (MAYBE 9241110 OR 9182265). IT WAS REPORTED DURING DISCUSSION THAT OTHER RNS WERE HAVING SIMILAR EXPERIENCES, INCLUDING REQUIRING MANY ATTEMPTS TO GAIN ACCESS. AND TUBING ON THE CATHETER MALFUNCTIONED DESPITE HAVING JUST BEEN FLUSHED. PER CUSTOMER EMAIL: I JUST WANTED TO ALERT THIS GROUP THAT THIS MORNING WE HAD A 20 GA. IV CATHETER MALFUNCTION WHILE BEING INSERTED INTO A PATIENT. THE NEEDLE WOULD NOT COMPLETELY WITHDRAW FROM THE ASSEMBLY AND DESPITE MULTIPLE ATTEMPTS BY STAFF, WAS STUCK HALFWAY OUT OF THE ASSEMBLY. THE CATHETER WAS REMOVED AND THE RN PLACED AN IV ELSEWHERE. WHEN THE ED TEAM STARTED TO DISCUSS THE ISSUE, OTHER RNS REPORTED HAVING SIMILAR EXPERIENCES WITH THE IVS MALFUNCTIONING DURING INSERTION IN THE PAST FEW WEEKS, REQUIRING REPEAT ATTEMPTS FOR ACCESS. ONE RN SAID THAT HER PATIENT WENT TO CT AND THE TUBING ON THE CATHETER MALFUNCTIONED DESPITE HAVING JUST BEEN FLUSHED.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 BD NEXIVA DUAL PORT 20GA 1.00IN (1.1 MM X 25 MM) HAS BEEN FOUND WITH DEFECTIVE TUBING DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 383536, BATCH NO: UNKNOWN (MAYBE 9241110 OR 9182265). IT WAS REPORTED DURING DISCUSSION THAT OTHER RNS WERE HAVING SIMILAR EXPERIENCES, INCLUDING REQUIRING MANY ATTEMPTS TO GAIN ACCESS. AND TUBING ON THE CATHETER MALFUNCTIONED DESPITE HAVING JUST BEEN FLUSHED. PER CUSTOMER EMAIL: I JUST WANTED TO ALERT THIS GROUP THAT THIS MORNING WE HAD A 20 GA. IV CATHETER MALFUNCTION WHILE BEING INSERTED INTO A PATIENT. THE NEEDLE WOULD NOT COMPLETELY WITHDRAW FROM THE ASSEMBLY AND DESPITE MULTIPLE ATTEMPTS BY STAFF, WAS STUCK HALFWAY OUT OF THE ASSEMBLY. THE CATHETER WAS REMOVED AND THE RN PLACED AN IV ELSEWHERE. WHEN THE ED TEAM STARTED TO DISCUSS THE ISSUE, OTHER RNS REPORTED HAVING SIMILAR EXPERIENCES WITH THE IVS MALFUNCTIONING DURING INSERTION IN THE PAST FEW WEEKS, REQUIRING REPEAT ATTEMPTS FOR ACCESS. ONE RN SAID THAT HER PATIENT WENT TO CT AND THE TUBING ON THE CATHETER MALFUNCTIONED DESPITE HAVING JUST BEEN FLUSHED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1077610 BD NEXIVA DUAL PORT 20GA 1.00IN (1.1 MM X 25 MM) INTERVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. UNKNOWN 00382903835362

    Patients

    Seq Age Sex Outcome Treatment
    1 Other