MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD NEXIVA CATHETER; INTERVASCULAR CATHETER

Catalog Number UNKNOWN

Device Problem Positioning Failure (1158)

Patient Problems Extravasation (1842); Infiltration into Tissue (1931)

Event Date 10/16/2019

Event Type  Injury  

Manufacturer Narrative

Device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.Unknown manufacturer: 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.Therefore, bd corporate headquarters in (b)(4) has been listed and the (b)(4) fda registration number has been used for the manufacture report number.

Event Description

It was reported that an unspecified number of an unspecified bd nexiva catheter experienced infiltration which was noted during use, and was involved in a serious injury when the device infiltrated into the patient's arm tissue.The following information was provided by the initial reporter: material no.: unknown batch no.: unknown.Complaint 2 of 3.Per email: it is my understanding that you are receiving complaints about extravasation of isovue into patients arms during ct procedures using nexiva and nexiva diffusics.Currently you do not have product or lot numbers.This has happened at least 4 times over the last few weeks.The techs or rns in the er are placing the lines and report easy insertion and brisk blood return.During injection the contrast is not moving up the arm vein, however, it is pooling in the patients arms.The patients are reporting no pain and there is no swelling related to the injection.This sounds like the device was not in the patients vein since no contrast went up the arm and it infiltrated into the arm tissue.

Manufacturer Narrative

Correction: h.1.Type of reportable events: serious injury.H.6.Investigation summary: bd was not able to duplicate or confirm the customer¿s indicated failure as no sample, batch, or lot code was provided.This complaint will be entered into the complaint management system and will be tracked & trended for future occurrences.The complaint was deemed as mdr reportable therefore a submission will be performed.Shall a sample or lot number become available, the complaint will be re-opened and an investigation will take place.This complaint will be closed at this time.H3 other text : see section h.10.

Event Description

It was reported that an unspecified number of an unspecified bd nexiva catheter experienced infiltration which was noted during use, and was involved in a serious injury when the device infiltrated into the patient's arm tissue.The following information was provided by the initial reporter: material no.: unknown, batch no.: unknown.Complaint 2 of 3.Per email: it is my understanding that you are receiving complaints about extravasation of isovue into patients arms during ct procedures using nexiva and nexiva diffusics.Currently you do not have product or lot numbers.This has happened at least 4 times over the last few weeks.The techs or rns in the er are placing the lines and report easy insertion and brisk blood return.During injection the contrast is not moving up the arm vein, however, it is pooling in the patients arms.The patients are reporting no pain and there is no swelling related to the injection.This sounds like the device was not in the patients vein since no contrast went up the arm and it infiltrated into the arm tissue.

• Brand Name: UNSPECIFIED BD NEXIVA CATHETER
• Type of Device: INTERVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 9306802
• MDR Text Key: 173932355
• Report Number: 2243072-2019-02530
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: UNKNOWN
• 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: 11/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 10/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other