MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP; TRAY CAUTI TEMP SENS MF 16FR 10ML SAFE

Catalog Number	URO170816TSQ
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	06/06/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the facility on (b)(6) 2022, the foley catheter balloon split and the catheter fell out of the patient during a procedure.
Additional Manufacturer Narrative
According to the facility on (b)(6) 2022, the foley catheter balloon split and the catheter fell out of the patient during a procedure.Per the facility the foley catheter was noted to be out of the patient at the end of the procedure.According to the facility a new catheter was placed.No additional information was provided.The sample was returned for evaluation, but a definitive root cause could not be determined 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.

• Common Device Name: TRAY CAUTI TEMP SENS MF 16FR 10ML 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: 14917041
• Report Number: 1417592-2022-00097
• Device Sequence Number: 6204468
• Product Code: OHR
• UDI-Device Identifier: 10193489723427
• UDI-Public: 10193489723427
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 07/05/2022

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 Catalogue Number: URO170816TSQ
• Device Lot Number: 592201210
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/14/2022
• Initial Report FDA Received Date: 07/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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