VASCULAR PROBES 7081015ES

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-29 for VASCULAR PROBES 7081015ES manufactured by Baxter Healthcare - Saint Paul.

Event Text Entries

[145023058] The actual sample was received for evaluation. A visual inspection was performed and noted no particulate matter. The reported issue was not verified. It was found during inspection that the probe was bent. The cause of the condition was determined to be manufacturing related. 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

[145023059] This report summarizes 1 malfunction event. It was reported that particulate matter was observed within the inner pouch of a surgical tool probe. The particulate matter was observed during inspection and prior to patient use. There was no patient involvement. No additional information is available.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1416980-2019-02370
• MDR Report Key: 8560009
• Date Received: 2019-04-29
• Date of Report: 2019-04-29
• Date Mfgr Received: 2019-03-31
• Date Added to Maude: 2019-04-29
• 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: 3

Device Details

• Brand Name: VASCULAR PROBES
• Generic Name: DILATOR, VESSEL, SURGICAL
• Product Code: DWP
• Date Received: 2019-04-29
• Model Number: NA
• Catalog Number: 7081015ES
• Lot Number: SP18J021327946
• 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		2019-04-29