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

Model Number 383517

Device Problem Leak/Splash (1354)

Patient Problems Extravasation (1842); Venipuncture (2129)

Event Date 07/01/2020

Event Type  Injury  

Manufacturer Narrative

Medical device expiration date: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.(b)(4).

Event Description

It was reported that bd nexiva¿ closed iv catheter system was used and extravasation occurred.This was discovered during use.The following information was provided by the initial reporter: material no: 383517 batch no: unknown.It was reported that iv attempt in ac on one arm unsuccessful, attempted ac in the other arm - unsuccessful, when back to original arm and placement was successful.Extravasation occurred.Levaquin was administered.

Event Description

It was reported that bd nexiva¿ closed iv catheter system was used and extravasation occurred.This was discovered during use.The following information was provided by the initial reporter: material no: 383517 batch no: unknown.It was reported that iv attempt in ac on one arm unsuccessful, attempted ac in the other arm - unsuccessful, when back to original arm and placement was successful.Extravasation occurred.Levaquin was administered.

Manufacturer Narrative

Investigation: bd was unable to  perform a thorough investigation as no sample, lot, or batch number were provided.Dhr could not be performed due to the unknown lot#.The complaint could not be confirmed and the root cause is undetermined.

• 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
• MDR Report Key: 10312260
• MDR Text Key: 200042379
• Report Number: 1710034-2020-00474
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903835172
• UDI-Public: 30382903835172
• Combination Product (y/n): N
• PMA/PMN Number: K183399
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 08/18/2020

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
• Device Operator: Other
• Device Model Number: 383517
• Device Catalogue Number: 383517
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/02/2020
• Initial Date FDA Received: 07/23/2020
• Supplement Dates Manufacturer Received: 07/02/2020
• Supplement Dates FDA Received: 08/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention