VASCULAR PROBES 7151520

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-29 for VASCULAR PROBES 7151520 manufactured by Baxter Healthcare - Saint Paul.

Event Text Entries

[125639862] The device was received for evaluation. The returned unit was labeled for single use. Visual inspection revealed particulate matter on the outside wall of the inner pouch. Microscopic inspection revealed that the particulate matter was a fiber. The reported condition was verified. The cause of the condition was not determined. A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot. Should additional relevant information become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10

[125639863] This report summarizes 1 malfunction events. It was reported that particulate matter was found inside the inner pouch of a vascular probe. There was no patient involvement. No additional information is available.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1416980-2018-06871
• MDR Report Key: 8014613
• Date Received: 2018-10-29
• Date of Report: 2018-10-29
• Date Mfgr Received: 2018-09-30
• Date Added to Maude: 2018-10-29
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 0
• Initial Report to FDA: 0
• Report to FDA: 3
• Event Location: 3
• Manufacturer Street: 25212 W. ILLINOIS ROUTE 120
• Manufacturer City: ROUND LAKE IL 60073
• Manufacturer Country: US
• Manufacturer Postal: 60073
• Manufacturer Phone: 2242702068
• Manufacturer G1: BAXTER HEALTHCARE - SAINT PAUL
• Manufacturer Street: 2575 UNIVERSITY AVE W
• Manufacturer City: SAINT PAUL MN 55114
• Manufacturer Country: US
• Manufacturer Postal Code: 55114
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Details

• Brand Name: VASCULAR PROBES
• Generic Name: DILATOR, VESSEL, SURGICAL
• Product Code: DWP
• Date Received: 2018-10-29
• Model Number: NA
• Catalog Number: 7151520
• Lot Number: SP18D161300772
• Device Availability: *
• Device Eval'ed by Mfgr: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: BAXTER HEALTHCARE - SAINT PAUL
• Manufacturer Address: SAINT PAUL MN

Patients

Patient Number	Treatment	Outcome	Date
1	0		2018-10-29