MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; TOTAL TRAY 14FR URNMTR 100% SIL

Catalog Number UROT1070

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Local Reaction (2035)

Event Date 01/01/2020

Event Type  malfunction  

Manufacturer Narrative

It was reported that an unidentified number of patients post foley catheter insertion attempts developed different symptoms ranging from hematuria, false passage, and urethra trauma.The facility initially reported these patients required cystoscopies due to trauma and injury.Some patients required a foley catheter post discharged.No additional information is available at this time.Despite multiple good faith efforts to obtain additional information, the customer contact was unable or unwilling to provide further incident details to the manufacturer.The sample(s) have not been returned for evaluation.Due to the reported incident and in an abundance of caution, this medwatch is filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

Event Description

It was reported that an unidentified number of patients post foley catheter insertion attempts developed different symptoms ranging from hematuria, false passage, and urethra trauma.

• Type of Device: TOTAL TRAY 14FR URNMTR 100% SIL
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield, il
• Manufacturer Contact: teresa maynard ; three lakes drive; northfield, il ; 9311514
• MDR Report Key: 9959162
• MDR Text Key: 188007106
• Report Number: 1417592-2020-00032
• Device Sequence Number: 1
• Product Code: EZL
• 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: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 04/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UROT1070
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/24/2020
• Initial Date FDA Received: 04/14/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: 1400670000-20208003
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention