MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; 1LYR 16FR10ML 100%SIL TMP SAFE

Catalog Number URO170816TQ

Device Problem Fluid/Blood Leak (1250)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/26/2023

Event Type  Injury  

Manufacturer Narrative

According to the facility on (b)(6)2023 "foley catheter was leaking and the catheter was removed and a new one was placed".Per the facility the balloon was tested prior to insertion and 10cc's were used to inflate the balloon.The catheter was used in an acute care setting and there were no issues identified at the time.No additional information is available at this time.The sample is not available to be returned for evaluation.It has been determined that the reported event caused or contributed to serious injury requiring medical intervention, therefore, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

Event Description

According to the facility on (b)(6) 2023 "foley catheter was leaking and the catheter was removed and a new one was placed".

• Type of Device: 1LYR 16FR10ML 100%SIL TMP SAFE
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: justin herrmann ; three lakes drive; northfield, IL 60093
• MDR Report Key: 16393002
• MDR Text Key: 309742267
• Report Number: 1417592-2023-00062
• 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: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: URO170816TQ
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/09/2023
• 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
• Patient Outcome(s): Other
• Patient Age: 76 YR
• Patient Sex: Female
• Patient Weight: 81 KG