MAUDE Adverse Event Report: BD BD INSTYLE AUTOGUARD; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number 381423

Device Problems Material Integrity Problem (2978); Output Problem (3005)

Patient Problem Insufficient Information (4580)

Event Date 01/13/2022

Event Type  malfunction  

Event Description

Change in equipment condition; nurses report catheters do not smoothly slide off of needle.Current catheters have a "gritty" feel when the catheter slides over the needle.Does not advance smoothly.

• Brand Name: BD INSTYLE AUTOGUARD
• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): BD; 5859 farinon dr ste 200; san antonio TX 78249
• MDR Report Key: 13584005
• MDR Text Key: 285995017
• Report Number: 13584005
• 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: 02/07/2022,01/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 381423
• Device Catalogue Number: 381423
• Device Lot Number: 1238769
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/07/2022
• Date Report to Manufacturer: 02/23/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1