MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD NEXIVA¿ CLOSED IV CATHETER SYSTEM - DUAL PORT 20 GA 1.00 IN; INTRAVASCULAR CATHETER

Model Number 383536

Device Problem Leak/Splash (1354)

Patient Problem Blood Loss (2597)

Event Date 01/26/2020

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: unknown.Device manufacture date: unknown.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 that bd nexiva closed iv catheter system - dual port 20 ga 1.00 in leaked during use.The following information was provided by the initial reporter: verbatim: ¿t was reported that when inserting a patient with an iv, a hole was noted in the plastic portion of the catheter which caused bleeding and removal of the iv.Concern description: when inserting iv in patient, a hole was noted in plastic portion of catheter (possibly plastic portion around pink triangular area).This caused bleeding and removal if iv.

Manufacturer Narrative

H.6.Investigation: since no samples displaying the condition reported were available for examination, we were unable to fully investigate this incident.A device history record review showed no non-conformances associated with this issue during the production of this batch.The complaint could not be confirmed and the root cause is undetermined.

Event Description

It was reported that bd nexiva closed iv catheter system - dual port 20 ga 1.00 in leaked during use.The following information was provided by the initial reporter: verbatim: ¿t was reported that when inserting a patient with an iv, a hole was noted in the plastic portion of the catheter which caused bleeding and removal of the iv.Concern description: when inserting iv in patient, a hole was noted in plastic portion of catheter (possibly plastic portion around pink triangular area).This caused bleeding and removal if iv.

• Brand Name: BD NEXIVA¿ CLOSED IV CATHETER SYSTEM - DUAL PORT 20 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
• MDR Report Key: 9732861
• MDR Text Key: 183891541
• Report Number: 1710034-2020-00097
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903835363
• UDI-Public: 30382903835363
• Combination Product (y/n): N
• PMA/PMN Number: K183399
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Type of Report: Initial,Followup
• Report Date: 03/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 383536
• Device Catalogue Number: 383536
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 01/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other