MAUDE Adverse Event Report: BD INSYTE AUTOGUARD; CATHETER, INTRAVENOUS, SHORT TERM

Lot Number 6251800

Device Problems Failure to Read Input Signal (1581); Sticking (1597)

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

Event Date 12/07/2016

Event Type  malfunction  

Event Description

An iv attempt was being made on a patient in the surgical icu.When the button on the safety iv catheter was depressed, to engage the safety device, the button remained depressed and the safety device failed to engage.Manufacturer response for autoguard iv catheter, insyte (per site reporter): had to leave a message with the quality department.

• Brand Name: INSYTE AUTOGUARD
• Type of Device: CATHETER, INTRAVENOUS, SHORT TERM
• Manufacturer (Section D): BD; 5859 farinon dr. ste 200; san antonio TX 78249
• MDR Report Key: 6215529
• MDR Text Key: 63638228
• Report Number: 6215529
• 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: 12/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2016
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Lot Number: 6251800
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/12/2016
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 12/12/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO
• Patient Age: 69 YR