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

Model Number UROT1098

Device Problem Break (1069)

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

Event Date 06/01/2022

Event Type  malfunction  

Event Description

It was reported by the facility that the foley catheter balloon broke on inflation while in the patient.

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.

• Brand Name: Medline
• Type of Device: 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: 14848803
• MDR Text Key: 295069424
• Report Number: 1417592-2022-00091
• Device Sequence Number: 1
• Product Code: OHR
• UDI-Device Identifier: 10193489491074
• UDI-Public: 10193489491074
• 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: 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
• Device Operator: Health Professional
• Device Model Number: UROT1098
• Device Catalogue Number: UROT1098
• Device Lot Number: 22DBC873
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/03/2022
• Initial Date FDA Received: 06/28/2022
• 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): Required Intervention