MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD NEXIVA¿ CLOSED PERIPHERAL IV CATHETER SYSTEM; INTRAVASCULAR CATHETER

Catalog Number UNKNOWN

Device Problem Deformation Due to Compressive Stress (2889)

Patient Problem Insufficient Information (4580)

Event Date 07/17/2022

Event Type  malfunction  

Manufacturer Narrative

There are multiple bd locations where this unspecified bd device may have been manufactured.A catalog and lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured.(b)(4).The date received by manufacturer has been used for this.Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation and/or device history review, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported that while using an unspecified bd nexiva¿ closed peripheral iv catheter system kinked.The following information was provided by the initial reporter: "nexiva kinked.".

Manufacturer Narrative

Investigation summary: there was no sample or photo available to bd for evaluation.Therefore, bd was unable to perform a thorough investigation to verify the reported issue.Since, an investigation could not be performed bd was unable to determine a possible root cause.The manufacturing facility has been notified of this event but without a sample no corrective actions could be identified.A review of the device history record could not be performed as the lot number was unknown.

Event Description

It was reported that while using an unspecified bd nexiva¿ closed peripheral iv catheter system kinked.The following information was provided by the initial reporter: nexiva kinked.

• Brand Name: UNSPECIFIED BD NEXIVA¿ CLOSED PERIPHERAL IV CATHETER SYSTEM
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15214821
• MDR Text Key: 305153267
• Report Number: 2243072-2022-01327
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/30/2022
• 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