MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; TTL1LYR 16FR10ML 100%SIL UM SAFESECURE

Catalog Number URO170816Q

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

Patient Problem Local Reaction (2035)

Event Date 04/11/2020

Event Type  malfunction  

Manufacturer Narrative

It was reported a patient was olguric for several shifts with unsuccessful bladder irrigations.Reporter states that during their shift on (b)(6) 2020, patients "creatinine had risen up to 10".Foley catheter removed and a new one placed without reported incident.Reporter state's creatinine gradually began to decrease and urine color turned clear.No additional information is available at this time.There was no further intervention reported related to the incident.The sample is not available for returned and 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 patient had oligurgia for several shifts, "creatinine had risen to 10".Foley catheter removed and a new one placed without reported incident.

• Type of Device: TTL1LYR 16FR10ML 100%SIL UM SAFESECURE
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield, il
• Manufacturer Contact: teresa maynard ; three lakes drive; northfield, il
• MDR Report Key: 10070841
• MDR Text Key: 205118660
• Report Number: 1417592-2020-00045
• 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: health professional,user faci
• Reporter Occupation: Nurse Practitioner
• Type of Report: Initial
• Report Date: 05/19/2020

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: URO170816Q
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/21/2020
• Initial Date FDA Received: 05/19/2020
• 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
• Patient Sequence Number: 1