MAUDE Adverse Event Report: BAXTER HEALTHCARE - SAINT PAUL VASCULAR PROBES; DILATOR, VESSEL, SURGICAL

Catalog Number 7081015

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Type  malfunction  

Manufacturer Narrative

The device was received for evaluation.The returned unit was labeled for singe 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 size of the particulate matter was found to be within specification for this device.The device was found to be conforming product.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.

Event Description

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.

• Brand Name: VASCULAR PROBES
• Type of Device: DILATOR, VESSEL, SURGICAL
• Manufacturer (Section D): BAXTER HEALTHCARE - SAINT PAUL; saint paul MN
• Manufacturer (Section G): BAXTER HEALTHCARE - SAINT PAUL; 2575 university ave w; saint paul MN 55114
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 8014841
• MDR Text Key: 125638132
• Report Number: 1416980-2018-06878
• Device Sequence Number: 1
• Product Code: DWP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Type of Report: Initial
• Report Date: 10/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: 7081015
• Device Lot Number: SP18C071294188
• Initial Date Manufacturer Received: 09/30/2018
• Initial Date FDA Received: 10/29/2018
• Type of Device Usage: N
• Patient Sequence Number: 1