MAUDE Adverse Event Report: BAXTER HEALTHCARE - SAINT PAUL FLO-THRU; CLAMP, VASCULAR

Catalog Number FT12250

Device Problem Delivered as Unsterile Product (1421)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The actual sample was received for evaluation.The returned unit was labeled for single use.Visual inspection of the returned unit was performed and noted a fiber on the inner pouch.The reported condition was verified.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.

Event Description

This report summarizes 1 malfunction event.It was reported that particulate matter was observed in the inner pouch of a flo-thru intraluminal shunt.The particulate matter was discovered prior to patient use.There was no patient involvement.No additional information is available.

• Brand Name: FLO-THRU
• Type of Device: CLAMP, VASCULAR
• 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: 8558068
• MDR Text Key: 144730034
• Report Number: 1416980-2019-02351
• Device Sequence Number: 1
• Product Code: DXC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Type of Report: Initial
• Report Date: 04/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: FT12250
• Device Lot Number: SP18K161337357
• Date Manufacturer Received: 03/31/2019
• Type of Device Usage: N
• Patient Sequence Number: 1