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

Catalog Number 383647

Device Problem Leak/Splash (1354)

Patient Problem Blood Loss (2597)

Event Date 03/10/2020

Event Type  malfunction  

Manufacturer Narrative

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 5 bd nexiva¿ closed iv catheter systems' filter's were "either not attached or loose", and placing the line caused blood to leak out of them.The following information was provided by the initial reporter: "faulty nexiva.We¿ve had a run of about 5 (that i know of) 20g lines where the filters are either not attached or loose, and so when placing the line, blood has leaked out.".

Event Description

It was reported that 5 bd nexiva¿ closed iv catheter systems' filter's were "either not attached or loose", and placing the line caused blood to leak out of them.The following information was provided by the initial reporter: "faulty nexiva we¿ve had a run of about 5 (that i know of) 20g lines where the filters are either not attached or loose, and so when placing the line, blood has leaked out.".

Manufacturer Narrative

H.6.Investigation: our quality engineer inspected the photographs submitted for evaluation.Bd received two photographs which displayed the top web label information and a view of the bottom web blister.The blister contains a 20g bd nexiva dual-port and the blue cap.There is a q-syte attached to one adapter port (luer) while the vent plug is loosened from the second adapter port (luer).The package is undamaged.Although the reported defect of ¿leakage¿ could not be identified or confirmed, the photos disclosed the vent plug was loosened from the nexiva unit.This confirms the defect of vent plug loose/missing which could be result in leakage.Loose vent plugs in the packaging can occur during the handling of the device.When the vent plug is inserted into the luer adapter, it is done at a specified force during manufacturing.The next process is sterilization, where the unit can go through a relaxation period and has the effect to loosen the plug.The evidence provided confirms this to be a manufacturing design issue.A device history record review showed no non-conformances associated with this issue during the production of this batch.H3 other text : see h.10.

• 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: 9900159
• MDR Text Key: 187541708
• Report Number: 1710034-2020-00219
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: K183399
• 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: 05/22/2020

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 Expiration Date: 09/30/2022
• Device Catalogue Number: 383647
• Device Lot Number: 9284508
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/10/2020
• Initial Date FDA Received: 03/30/2020
• Supplement Dates Manufacturer Received: 03/10/2020
• Supplement Dates FDA Received: 05/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other