MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC.; FOLEY CATHETER TRAY

Catalog Number URO170716

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Hematuria (2558)

Event Type  Injury  

Manufacturer Narrative

A labor and delivery patient developed hematuria after a catheter had been inserted and the facility believed it may have been caused by the catheter.We have limited information pertaining to the incident.The sample was returned and evaluated.No visual malformations were identified.There were no noted flaws in the catheter.We cannot confirm the catheter caused or contributed to the incident.It is unknown if other contributing factors existed which may have played a role in the hematuria.Due to the reported incident and in an abundance of caution, this medwatch is being filed.

Event Description

The patient developed hematuria which the facility believed may have been caused by the catheter.

• Type of Device: FOLEY CATHETER TRAY
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; one medline place; mundelein IL 60060
• Manufacturer Contact: julie finley ; one medline place; mundelein, IL 60060 ; 8476434709
• MDR Report Key: 5772880
• MDR Text Key: 48882167
• Report Number: 1417592-2016-00072
• Device Sequence Number: 1
• Product Code: OHR
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Nurse
• Device Catalogue Number: URO170716
• Device Lot Number: 16DBD3234
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Date Manufacturer Received: 06/10/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other