MAUDE Adverse Event Report: BECTON DICKINSON BD NEXIVA DIFFUSICS CLOSED IV CATHETER SYSTEM; INTRAVENOUS CATHETER

Catalog Number UNKNOWN

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Extravasation (1842); Hemorrhage/Bleeding (1888)

Event Date 01/20/2018

Event Type  Injury  

Manufacturer Narrative

Medical device expiration date: unknown fda notified?: the initial reporter also notified the fda on (date) via medwatch # mw5075018.Device manufacture date: unknown.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, (b)(4) has been listed.And the (b)(4) fda registration number has been used for the manufacture report number.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 by medwatch that the unspecified bd nexiva diffusics closed iv catheter system caused a reaction in the patient who needed medical intervention.¿medwatch event description states, "a (b) (6) seen in er and found to have splenic hemorrhage.A 20 g diffusics catheter to right forearm was placed.Pt was taken emergently to operating room.Received normal salne and blood products through iv site.After procedure, right arm was untucked from drape and found to have significant extravasation.Underwent right forearm fasciotomy for compartment syndrome." customer needed a second procedure, fasciotomy, to address the compartment syndrome caused by the extravasation.

Manufacturer Narrative

Investigation summary: no samples or photos displaying the condition reported are available for examination, we are unable to fully investigate.Without defective sample or photo for us is very difficult to determinate the root of cause for this reason we were not able to associate the reported defect to the mfg.Process.It is not possible perform the dhr review due that batch number was not provided.Investigation conclusion: we could not found the exact root cause of the issue since no batch, no sample or photo was returned for evaluation.

• Brand Name: BD NEXIVA DIFFUSICS CLOSED IV CATHETER SYSTEM
• Type of Device: INTRAVENOUS CATHETER
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 7335751
• MDR Text Key: 102304954
• Report Number: 2243072-2018-00131
• 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: 03/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 02/28/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other