MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP Medline; 14FR 10ML 100% SIL FOLEY UM MF

Model Number	UROT1098
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	06/01/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported by the facility that the foley catheter balloon broke on inflation while in the patient.According to the facility was not tested prior to insertion.Per the facility the issue was discovered when confirming placement, as the 'catheter pulled straight out and you could see where the balloon had burst'.No additional information was provided.The sample is not available to be returned for evaluation.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
It was reported by the facility that the foley catheter balloon broke on inflation while in the patient.

• Brand Name: Medline
• Common Device Name: 14FR 10ML 100% SIL FOLEY UM MF
• 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: 14847317
• Report Number: 1417592-2022-00089
• Device Sequence Number: 2367407
• Product Code: OHR
• UDI-Device Identifier: 10193489491074
• UDI-Public: 10193489491074
• 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): 06/28/2022

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: UROT1098
• Device Catalogue Number: UROT1098
• Device Lot Number: 22DBC873
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/03/2022
• Initial Report FDA Received Date: 06/28/2022
• 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: Required Intervention
• Patient Sex: Unknown