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U.S. Department of Health and Human Services

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

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BECTON DICKINSON BD NEXIVA DIFFUSICS CLOSED IV CATHETER SYSTEM INTRAVENOUS CATHETER Back to Search Results
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.
 
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Brand NameBD NEXIVA DIFFUSICS CLOSED IV CATHETER SYSTEM
Type of DeviceINTRAVENOUS CATHETER
Manufacturer (Section D)
BECTON DICKINSON
1 becton drive
franklin lakes NJ 07417
MDR Report Key7335751
MDR Text Key102304954
Report Number2243072-2018-00131
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
PMA/PMN Number
UNKNOWN
Number of Events Reported1
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 Received03/13/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNKNOWN
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/28/2018
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 03/13/2018 Patient Sequence Number: 1
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