MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD NEXIVA¿ CLOSED IV CATHETER SYSTEM ¿ SINGLE PORT 22 GA 1.00 IN; INTRAVASCULAR CATHETER

Catalog Number 383512

Device Problems Retraction Problem (1536); Improper Flow or Infusion (2954)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/16/2022

Event Type  malfunction  

Manufacturer Narrative

A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported while using bd nexiva¿ closed iv catheter system ¿ single port 22 ga 1.00 in there were air bubbles in the line.There was no report of patient impact.The following information was provided by the initial reporter: bubbles forming in catheter.

Event Description

It was reported while using bd nexiva¿ closed iv catheter system ¿ single port 22 ga 1.00 in there were bubbles forming in the catheter and the safety mechanism did not disengage from the catheter.There was no report of patient impact.The following information was provided by the initial reporter: it was reported that bubbles forming in catheter add info rcvd 10/07/2022: we were just informed that the end user opened a case with bd directly and were informed that it looks like the catheter has not been threaded in all the way and the needle wasn¿t removed.

Manufacturer Narrative

The following fields were updated due to additional information: it was reported while using bd nexiva¿ closed iv catheter system ¿ single port 22 ga 1.00 in there were bubbles forming in the catheter and the safety mechanism did not disengage from the catheter.There was no report of patient impact.The following information was provided by the initial reporter: it was reported that bubbles forming in catheter add info rcvd 10/07/2022: we were just informed that the end user opened a case with bd directly and were informed that it looks like the catheter has not been threaded in all the way and the needle wasn¿t removed.

Manufacturer Narrative

H.6.Investigation summary: our quality engineer inspected the photographs submitted for evaluation.Bd received four photographs which displayed a 22ga x 1.00in nexiva single port unit.Through the visual inspection of the provided photos, it was discovered that the needle was injected into a patient with the needle retracted but not decoupled.There were air bubbles present in the catheter tubing.The reported issue was confirmed.Although the reported issue was confirmed, it could not be determined if the damage resulted from the manufacturing of the device or from the user environment.The photos provided for this incident did not present sufficient evidence to establish a definite root cause.Examination of the actual product involved may provide clarification as to the cause for the reported failure.A device history record review showed no non-conformances associated with this issue during the production of this batch.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business team regularly reviews the collected data for identification of emerging trends.

Event Description

It was reported while using bd nexiva¿ closed iv catheter system ¿ single port 22 ga 1.00 in there were bubbles forming in the catheter and the safety mechanism did not disengage from the catheter.There was no report of patient impact.The following information was provided by the initial reporter: it was reported that bubbles forming in catheter add info rcvd (b)(6)2022: we were just informed that the end user opened a case with bd directly and were informed that it looks like the catheter has not been threaded in all the way and the needle wasn¿t removed.

• Brand Name: BD NEXIVA¿ CLOSED IV CATHETER SYSTEM ¿ SINGLE PORT 22 GA 1.00 IN
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• Manufacturer (Section G): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15556410
• MDR Text Key: 305996711
• Report Number: 1710034-2022-00589
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903835126
• UDI-Public: 00382903835126
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K183399
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 11/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 383512
• Device Lot Number: 2104590
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/14/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1