MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY BD INSYTE AUTOGUARD; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number 382523

Device Problems Break (1069); Leak/Splash (1354)

Patient Problem Insufficient Information (4580)

Event Date 05/11/2021

Event Type  malfunction  

Event Description

There was successful insertion of right hand iv.Leaking was noted when attempting to flush.The j loop was changed and the iv connected to the hub of angio.It continued to leak.Iv was removed and successfully restarted with a new angio in the right ac.On inspection of the hub of angio, it was noted there was a chipped area a the same site where leak was noted.

• Brand Name: BD INSYTE AUTOGUARD
• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 12421035
• MDR Text Key: 269811855
• Report Number: 12421035
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 08/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 382523
• Device Catalogue Number: 382523
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/20/2021
• Event Location: Hospital
• Date Report to Manufacturer: 09/03/2021
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 19345 DA