• 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 INSYTE AUTOGUARD BCPRO 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 INSYTE AUTOGUARD BCPRO CATHETER Back to Search Results
Catalog Number UNKNOWN
Device Problem Retraction Problem (1536)
Patient Problems Exposure to Body Fluids (1745); Extravasation (1842); Needle Stick/Puncture (2462)
Event Date 04/13/2021
Event Type  Injury  
Manufacturer Narrative
Date of event: unknown. The date received by manufacturer has been used for this field. 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. Device manufacture date: unknown. Investigation summary: bd was unable to perform a thorough investigation as no sample, lot, or batch number were provided. Complaints received for this device and reported condition will continue to be tracked and trended. Information will be captured on trend reports and monitored monthly.  our business team regularly reviews the collected data for identification of emerging trends. 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.
 
Event Description
It was reported that unspecified bd¿ insyte autoguard bcpro catheter had a safety mechanism failure causing a needle stick injury after use on 2 occasions. The following information was provided by the initial reporter: material no: unknown batch no: unknown. It was reported via post market survey that the clinician encountered phlebitis (25), infiltration / extravasation (30), needlestick injury after use on patient after safety mechanism activation (2) and catheter occlusions (20).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameUNSPECIFIED BD INSYTE AUTOGUARD BCPRO CATHETER
Type of DeviceCATHETER
Manufacturer (Section D)
BECTON DICKINSON
1 becton drive
franklin lakes NJ 07417
Manufacturer (Section G)
BECTON DICKINSON
1 becton drive
franklin lakes NJ 07417
Manufacturer Contact
katie swenson
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key11815812
MDR Text Key250390935
Report Number2243072-2021-01430
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeSP
PMA/PMN Number
UNKNOWN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 05/04/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/12/2021
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 Received04/13/2021
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: 05/12/2021 Patient Sequence Number: 1
-
-