MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD NEXIVA¿ CLOSED IV CATHETER SYSTEM; INTRAVASCULAR CATHETER

Catalog Number 383512

Device Problem Air/Gas in Device (4062)

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

Event Date 09/14/2022

Event Type  malfunction  

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that 5 bd nexiva¿ closed iv catheter systems experienced air in line.The following information was provided by the initial reporter: nurse reported multiple occurrences of air bubbles.Tested multiple catheters on herself with the same issue, whereupon air bubbles were noted in the line.

Manufacturer Narrative

H6: investigation summary our quality engineer inspected the photographs submitted for evaluation.Bd received four photographs of 22ga x 1.00in nexiva single port units from number 2104590.Based on the photos provided, some air bubbles appear in the catheter and extension tubing.The reported issue of air bubbles was confirmed.Although air bubbles were confirmed, the photographs did not provide sufficient evidence to determine a root cause.A device history record review showed no non-conformances associated with this issue during the production of this batch.

Event Description

It was reported that 5 bd nexiva¿ closed iv catheter systems experienced air in line.The following information was provided by the initial reporter: nurse reported multiple occurrences of air bubbles.Tested multiple catheters on herself with the same issue, whereupon air bubbles were noted in the line.

• Brand Name: BD NEXIVA¿ CLOSED IV CATHETER SYSTEM
• 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: 15543205
• MDR Text Key: 306617937
• Report Number: 1710034-2022-00582
• 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: K102520
• 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
• Report Date: 11/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2022
• 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: 11/11/2022
• 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