MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD NEXIVA DUAL PORT 20GA 1.00IN (1.1 MM X 25 MM) INTERVASCULAR CATHETER

Catalog Number 383536

Device Problem Leak/Splash (1354)

Patient Problem Blood Loss (2597)

Event Date 10/01/2019

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown. The date received by manufacturer has been used for this field. 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 the bd nexiva dual port 20ga 1. 00in (1. 1 mm x 25 mm) experienced defective/damaged tubing and leakage during use. The following information was provided by the initial reporter: cannulated patient and noticed that there was a small hole in the tubing of the cannula which was causing blood to leak from the tube. The hole was located just below the clamp. Cannula is a bd 20 gauge lot 9169950, expiry:2022-05-31, ref 383536. Action taken: cannula discarded as contaminated with patient blood. Aware and will check all batches.

• Brand Name: BD NEXIVA DUAL PORT 20GA 1.00IN (1.1 MM X 25 MM)
• Type of Device: INTERVASCULAR 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: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652341
• MDR Report Key: 9194327
• MDR Text Key: 172705243
• Report Number: 1710034-2019-01114
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K183399
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 383536
• Device Lot Number: 9169950
• Was Device Available for Evaluation?: No Answer Provided
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 10/01/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/18/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 10/15/2019 Patient Sequence Number: 1