MAUDE Adverse Event Report: BD INSYTE-N AUTOGUARD WINGED CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Lot Number 6133854

Device Problems Break (1069); Detachment Of Device Component (1104)

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

Event Date 09/30/2016

Event Type  malfunction  

Event Description

Iv catheter found to be sheared. Manufacturer response for iv catheter, insyte-n autoguard winged (per site reporter): previously reported issue that is reoccurring.

• Brand Name: INSYTE-N AUTOGUARD WINGED
• 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: 6124335
• MDR Text Key: 60787310
• Report Number: 6124335
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility

Reporter Occupation

• Type of Report: Initial
• Report Date: 10/18/2016

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 11/23/2016
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 04/30/2019
• Device Lot Number: 6133854
• Was Device Available for Evaluation?: No Answer Provided

Is the Reporter a Health Professional?

• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/18/2016
• Event Location: Hospital
• Date Report to Manufacturer: 10/18/2016
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Is the Device Single Use?: No Answer Provided
• Is This a Reprocessed and Reused Single-Use Device?: No

Type of Device Usage