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 Failure to Advance (2524); Material Twisted/Bent (2981); Physical Resistance/Sticking (4012)

Patient Problem No Code Available (3191)

Event Date 09/05/2019

Event Type  malfunction  

Event Description

Rn attempted to start piv.Once blood return/flash was seen the rn attempted to thread the catheter through vein but there was resistance and catheter would not thread through.Pt was uncomfortable, iv needle and catheter removed immediately.When rn looked at iv needle the needle was not bent but the plastic catheter was bent upwards.

• 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 dr; franklin lakes NJ 07417
• MDR Report Key: 9250596
• MDR Text Key: 164128334
• Report Number: 9250596
• 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
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 382523
• Device Catalogue Number: 382523
• Device Lot Number: 91089785
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/18/2019
• Event Location: Ambulatory Surgical Facility
• Date Report to Manufacturer: 10/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 19710 DA