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

Model Number	URO170816
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	09/28/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the facility on (b)(6) 2022 the patient was brought into the operating room for a procedure and a foley catheter was placed after the patient was positioned.Per the facility upon draping the patient the foley catheter came out and upon inspection the balloon was busted.An additional catheter was then placed while the patient was in recovery.The sample is not available to be returned for evaluation.No additional information is available at this time.Due to the reported incident and 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 or Problem Description
According to the facility on (b)(6) 2022 the patient was brought into the operating room for a procedure and a foley catheter was placed after the patient was positioned.Per the facility upon draping the patient the foley catheter came out and upon inspection the balloon was busted.

• Brand Name: Medline
• Common Device Name: TTL1LYR 16FR10ML 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: 15700103
• Report Number: 1417592-2022-00206
• Device Sequence Number: 6258565
• Product Code: OHR
• UDI-Device Identifier: 10888277862623
• UDI-Public: 10888277862623
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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): 10/31/2022

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
• Operator of Device: Health Professional
• Device Model Number: URO170816
• Device Catalogue Number: URO170816
• Device Lot Number: 22NBA625
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/10/2022
• Initial Report FDA Received Date: 10/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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