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

Catalog Number 383517

Device Problems Leak/Splash (1354); Device Fell (4014)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/07/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(6).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 leaked.No serious injury or medical intervention was reported.Verbatim: "material no.: 383517, batch no.: 7335675.It was reported the hubs are leaking and the blood stopper falls off.Verbatim: leaking hubs, blood stopper falls off".

Manufacturer Narrative

H.6.Investigation: dhr review was done found 1 non-related qn (b)(4)-incorrect labeling-pkg) where disposition of the product, root cause and corrective action were applied according to the quality control plan.All other challenges, set-up and in process samples were performed per quality control plan without the actual sample for evaluation and testing there was no physical evidence to confirm or support manufacturing process related issues for the reported defect.

Event Description

It was reported that bd nexiva¿ closed iv catheter system leaked.No serious injury or medical intervention was reported.Verbatim: "material no.: 383517.Batch no.: 7335675.It was reported the hubs are leaking and the blood stopper falls off.Verbatim: leaking hubs, blood stopper falls off.".

• Brand Name: BD NEXIVA¿ CLOSED IV CATHETER SYSTEM
• Type of Device: INTERVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• MDR Report Key: 8453572
• MDR Text Key: 139989577
• Report Number: 1710034-2019-00333
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903835172
• UDI-Public: 30382903835172
• Combination Product (y/n): N
• PMA/PMN Number: K161777
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 05/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 11/30/2020
• Device Catalogue Number: 383517
• Device Lot Number: 7335675
• Date Manufacturer Received: 03/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other