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

Model Number 382534

Device Problem Defective Device (2588)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 09/22/2019

Event Type  malfunction  

Event Description

Rn stuck the patient with a 20g iv catheter.Upon insertion, i got blood flash, pushed the retract button on the needle and the entire catheter was pulled with the needle, came out of the patient.Patient began bleeding, which was controlled with direct pressure and pressure dressing.Rn stuck the patient for an iv the second time and this catheter began pouring blood out of the catheter hub, which is not supposed to happen according to products function.

• Brand Name: BD INSYTE 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: 9510751
• MDR Text Key: 172439935
• Report Number: 9510751
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903825349
• UDI-Public: (01)00382903825349
• 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: 12/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 382534
• Device Catalogue Number: 382534
• Device Lot Number: 9144842
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/16/2019
• Event Location: Hospital
• Date Report to Manufacturer: 12/23/2019
• Type of Device Usage: N
• Patient Sequence Number: 1