MAUDE Adverse Event Report: BECTON DICKINSON AND COMPANY BD INSYTE AUTOGUARD; CATHETER, INTRAVASCULAR, THERAPEUTIC

Model Number 382523

Device Problem Scratched Material (3020)

Patient Problem No Patient Involvement (2645)

Event Date 11/28/2017

Event Type  malfunction  

Event Description

Rn was preparing to access a peripheral iv on the patient and noticed the catheter was abnormal (edge was rough, and not smooth).She immediately brought it to the manager's attention.The catheter was not used and never reached the patient.

• Brand Name: BD INSYTE AUTOGUARD
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC
• Manufacturer (Section D): BECTON DICKINSON AND COMPANY; 9450 south state street; sandy UT 84070
• MDR Report Key: 7112314
• MDR Text Key: 94788563
• Report Number: 7112314
• 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: Other
• Type of Report: Initial
• Report Date: 11/30/2017,12/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Model Number: 382523
• Device Catalogue Number: 382523
• Device Lot Number: 6257655
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/30/2017
• Event Location: Hospital
• Date Report to Manufacturer: 11/30/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1