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

Model Number 382534

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Skin Irritation (2076); Discomfort (2330)

Event Date 01/23/2019

Event Type  malfunction  

Event Description

Patient had ct angiography of chest with contrast to rule out pulmonary embolus.Patient had a great running 20g iv that had meds going through it on a pump.Flushed iv with no issues and no pain.Injected saline with injector and then contrast and got great study.Patient had no pain.Went back in to disconnect and patient had a bump roughly a little larger than a quarter.Patient was then complaining of slight discomfort.It seemed to be a saline infiltrate because of the size and the fact that the study was perfect.Patient was returned to emergency department hold and rn informed.

• Brand Name: BD INSYTE AUTOGUARD
• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY; 9450 south state street; sandy UT 84070
• MDR Report Key: 8324948
• MDR Text Key: 135703676
• Report Number: 8324948
• 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: 01/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 382534
• Device Catalogue Number: 382534
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/29/2019
• Event Location: Hospital
• Date Report to Manufacturer: 02/11/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 24820 DA
• Patient Weight: 95