• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD¿ NEXIVA CATHETER INTRAVENOUS CATHETER

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BECTON DICKINSON UNSPECIFIED BD¿ NEXIVA CATHETER INTRAVENOUS CATHETER Back to Search Results
Catalog Number UNKNOWN
Device Problems Break (1069); Detachment Of Device Component (1104)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/18/2018
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. 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. 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 during insertion of the unspecified bd¿ nexiva catheter. The catheter tip broke off and lodged into the patients vein. The catheter tip was able to be retrieved at the insertion site without surgical intervention. No medical intervention given. No prolonged hospital time. No change in treatment required.
 
Manufacturer Narrative
Investigation summary: sample analysis - the catheter had been cut. The defect was confirmed through the investigation. Dhr review could not be performed as there is no lot number given. The severity of a catheter fragment that can be removed from the insertion site is limited. The occurrence of this incident does not exceed what is considered acceptable. Production causes of this defect type exist but were not confirmed through the investigation. The severity of the defect is limited and the occurrence is low. No additional actions need to be taken at this time.
 
Event Description
It was reported during insertion of the unspecified bd¿ nexiva catheter. The catheter tip broke off and lodged into the patients vein. The catheter tip was able to be retrieved at the insertion site without surgical intervention. No medical intervention given. No prolonged hospital time. No change in treatment required.
 
Manufacturer Narrative
Due to an it issue beginning on (b)(6) 2018, previously filed emdrs did not contain required fields. This supplemental emdr is filed to provide the following omitted fields: sex: unknown. Event attributed to: other. Device single use?: no. Device returned to manufacture: yes.
 
Event Description
It was reported during insertion of the unspecified bd nexiva catheter. The catheter tip broke off and lodged into the patients vein. The catheter tip was able to be retrieved at the insertion site without surgical intervention. No medical intervention given. No prolonged hospital time. No change in treatment required.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameUNSPECIFIED BD¿ NEXIVA CATHETER
Type of DeviceINTRAVENOUS CATHETER
Manufacturer (Section D)
BECTON DICKINSON
1 becton drive
franklin lakes NJ 07417
MDR Report Key7498705
MDR Text Key108256208
Report Number2243072-2018-00278
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 health professional,other,use
Type of Report Initial,Followup,Followup
Report Date 08/20/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/09/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
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 Received04/20/2018
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 05/09/2018 Patient Sequence Number: 1
-
-