MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD NEXIVA¿ CLOSED IV CATHETER SYSTEM - DUAL PORT 18 GA 1.25 IN; INTRAVASCULAR CATHETER

Catalog Number	383545
Medical Device Problem Codes	Leak/Splash (1354); Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/02/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that leakage occurred during use with a bd nexiva¿ closed iv catheter system - dual port 18 ga 1.25 in.The following information was provided by the initial reporter, "this morning we have had a failure of a number 18 iv cannula.Inserted well, but started spewing blood from the catheter right close to the wings.When looked closely at the cathelon, we saw blood spewing from a hole in the catheter.".
Additional Manufacturer Narrative
Investigation: a device history record review was completed by our quality engineer team for provided lot number 7083671.The review did not reveal any detected abnormalities during the production process that could have contributed to this defect and all quality tests were found to be within specification.As a sample was unavailable for return, a thorough sample investigation could not be completed.Based on the investigation results, an exact cause for this incident could not be identified.
Event or Problem Description
It was reported that leakage occurred during use with a bd nexiva¿ closed iv catheter system - dual port 18 ga 1.25 in.The following information was provided by the initial reporter, "this morning we have had a failure of a number 18 iv cannula.Inserted well, but started spewing blood from the catheter right close to the wings.When looked closely at the cathelon, we saw blood spewing from a hole in the catheter.".

• Brand Name: BD NEXIVA¿ CLOSED IV CATHETER SYSTEM - DUAL PORT 18 GA 1.25 IN
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• MDR Report Key: 9766040
• Report Number: 1710034-2020-00123
• Device Sequence Number: 2886316
• Product Code: FOZ
• UDI-Device Identifier: 30382903835455
• UDI-Public: 30382903835455
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K183399
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 03/31/2020
• Device Catalogue Number: 383545
• Device Lot Number: 7083671
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/07/2020
• Supplement Date Received by Manufacturer: 02/07/2020
• Initial Report FDA Received Date: 02/27/2020
• Supplement Report FDA Received Date: 05/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other