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


  • 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

Catalog Number UNKNOWN
Device Problems Malposition of Device (2616); No Flow (2991)
Patient Problem Extravasation (1842)
Event Date 10/19/2019
Event Type  malfunction  
Manufacturer Narrative
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. Medical device expiration date: unknown. A device evaluation and/or device history review is anticipated, but is not complete. Upon completion, a supplemental report will be filed. Device manufacture date: unknown.
Event Description
It was reported that unspecified bd¿ catheter infiltrated the patient's vein. This was discovered during use. The following information was provided by the initial reporter: material no. : unknown. Batch no. : unknown. It was reported that the needle infiltrated the patient's vein because the contrast was not flowing through the patient's arm. Pr 3 of 3: this pr is for date (b)(6) 2019 out of 3 dates. It is my understanding that you are receiving complaints from the ct department 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 ct 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.
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Type of DeviceCATHETER
Manufacturer (Section D)
1 becton drive
franklin lakes NJ 07417
Manufacturer (Section G)
1 becton drive
franklin lakes NJ 07417
Manufacturer Contact
brett wilko
9450 south state street
sandy, UT 84070
MDR Report Key9306725
MDR Text Key171979639
Report Number2243072-2019-02529
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
Number of Events Reported1
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 11/19/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/11/2019
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
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/21/2019
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 Treatment Data
Date Received: 11/11/2019 Patient Sequence Number: 1