MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP; TTL1LYR 16FR10ML 100%SILI UM TRAY

Catalog Number	URO170816
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	03/15/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the customer on 3/15, "a foley was inserted before the start of a robotic assisted total laparoscopic hysterectomy and the balloon was found to have been ruptured when scrub tech and rn were going to do a bladder back fill.
Additional Manufacturer Narrative
According to the customer on 3/15, "a foley was inserted before the start of a robotic assisted total laparoscopic hysterectomy and the balloon was found to have been ruptured when scrub tech and rn were going to do a bladder back fill.The catheter was in place for approximately 30 minutes".The customer reported that "a second foley was inserted and stayed in place for 5 minutes but the balloon ruptured for this foley as well.A single 16 fr dual chamber foley that was not part of a kit was inserted and stayed in place".The customer did not report any serious injury and stated that there were no issues with the patient.According to the customer there is no sample for evaluation.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.

• Common Device Name: TTL1LYR 16FR10ML 100%SILI UM TRAY
• Manufacturer (Section D): MEDLINE INDUSTRIES LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: alex mathew ; three lakes drive; northfield, IL 60093 ; 2249317042
• MDR Report Key: 19106756
• Report Number: 1417592-2024-00500
• Device Sequence Number: 17994018
• Product Code: OHR
• UDI-Device Identifier: 40888277862624
• UDI-Public: 40888277862624
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/15/2024

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?: No
• Device Catalogue Number: URO170816
• Device Lot Number: 23GBQ005
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/18/2024
• Initial Report FDA Received Date: 04/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown