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

Catalog Number 383516

Device Problem Air/Gas in Device (4062)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/18/2023

Event Type  malfunction  

Manufacturer Narrative

D.4.Medical device expiration date: unknown.H.3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.H.4.Device manufacture date: unknown.

Event Description

It was reported that the bd nexiva¿ closed iv catheter system tubing expanded when used with the power injector.The following information was provided by the initial reporter: "re cat 383516 nexiva - customer claims "bd nexiva used for ct scan with power injector.Psi was under pressure limit of 300psi.Db nexiva catheter dilatated from wings of iv to the two port hub."".

Manufacturer Narrative

Investigation summary bd was unable to perform a thorough investigation as no sample, lot, or batch number were provided.A device history review could not be completed as no batch number was provided.

Event Description

It was reported that the bd nexiva¿ closed iv catheter system tubing expanded when used with the power injector.The following information was provided by the initial reporter: "re cat 383516 nexiva - customer claims "bd nexiva used for ct scan with power injector.Psi was under pressure limit of 300psi.Db nexiva catheter dilatated from wings of iv to the two port hub."".

• 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
• Manufacturer (Section G): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• Manufacturer Contact: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17770159
• MDR Text Key: 323844316
• Report Number: 1710034-2023-01073
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903835164
• UDI-Public: 00382903835164
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K183399
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 383516
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/31/2023
• Initial Date FDA Received: 09/18/2023
• Supplement Dates Manufacturer Received: 10/17/2023
• Supplement Dates FDA Received: 10/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1