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

Catalog Number 381412

Device Problems Material Invagination (1336); Use of Device Problem (1670); Failure to Cut (2587)

Patient Problem Insufficient Information (4580)

Event Date 05/24/2021

Event Type  malfunction  

Event Description

With this iv catheter, the needle does not puncture the skin easily, and the catheter actually wrinkles up on itself if you try to force it through the skin.This has occurred to this nurse personally 3 times, and 2 other staff members stated they had also seen it.This is only with insyte autoguard 24ga x075 in catheter.The lot number of today's occurrence is 0195393.Manufacturer response for piv catheter, insyte autoguard (per site reporter).Manufacturer is investigating.

• Brand Name: 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: 12092028
• MDR Text Key: 259156974
• Report Number: 12092028
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 381412
• Device Lot Number: 195393
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/09/2021
• Event Location: Hospital
• Date Report to Manufacturer: 06/30/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 730 DA
• Patient Weight: 10