MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP Medline; 1LYR 16FR 10ML 100%SILI UM TRAY

Model Number DYND160816

Device Problem Leak/Splash (1354)

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

Event Date 01/09/2023

Event Type  Injury  

Manufacturer Narrative

According to the facility on (b)(6) 2023, "a registered nurse noted leaking when moving the urometer bag from sterile container to hang on bed".Per the facility, "urometer bag was cracked in multiple places and the patient had an additional foley catheter placed".The sample is not available to be returned for evaluation.No additional information is available at this time.It has been determined that the reported event could cause or contribute to serious injury if it were to occur.In an abundance of caution, 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, "a registered nurse noted leaking when moving the urometer bag from sterile container to hang on bed".

• Brand Name: Medline
• Type of Device: 1LYR 16FR 10ML 100%SILI UM TRAY
• 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: 16229544
• MDR Text Key: 307974754
• Report Number: 1417592-2023-00033
• Device Sequence Number: 1
• Product Code: OHR
• UDI-Device Identifier: 10884389286296
• UDI-Public: 10884389286296
• 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: 01/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: DYND160816
• Device Catalogue Number: DYND160816
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/11/2023
• 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