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

Model Number 381411

Device Problem Material Frayed (1262)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/14/2019

Event Type  malfunction  

Event Description

Attempted lab draws two times from patient using bd insyte-n autoguard 24ga x 0.56in catheter.Both catheters frayed/splintered inside the patient.This immediately stopped both lab draws and forced more pokes to the patient.Both catheters came from the same lot.

• Brand Name: INSYTE-N 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: 8955138
• MDR Text Key: 156310077
• Report Number: 8955138
• 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: 08/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 381411
• Device Catalogue Number: 381411
• Device Lot Number: 9024526
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/15/2019
• Event Location: Hospital
• Date Report to Manufacturer: 09/03/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 30 DA