MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP Medline; CATHETER,FOLEY,100%SILICONE,14FR,10ML,LF

Model Number	DYND11501
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	06/10/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the facility on (b)(6) 2022 the residents catheter tubing was discovered to be broken, leaving a portion of the tubing inside the resident's urethra.Per the facility the catheter was placed on (b)(6) 2022 with no problems noted at the time of insertion.Per the facility when the nurse attempted to remove the catheter there was noted resistance as 'they were unable to deflate the balloon'.The resident was sent to the emergency room where a new catheter was placed without issue.Per the facility there was no adverse effects related to the incident with the catheter.No additional information was provided.The actual sample was not 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
According to the facility on (b)(6) 2022 the residents catheter tubing was discovered to be broken, leaving a portion of the tubing inside the resident's urethra.

• Brand Name: Medline
• Common Device Name: CATHETER,FOLEY,100%SILICONE,14FR,10ML,LF
• 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: 14864599
• Report Number: 1417592-2022-00093
• Device Sequence Number: 5102560
• Product Code: EZL
• UDI-Device Identifier: 10884389034439
• UDI-Public: 10884389034439
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 06/29/2022

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: DYND11501
• Device Catalogue Number: DYND11501
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/10/2022
• Initial Report FDA Received Date: 06/29/2022
• 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: Male
• Patient Weight: 64 KG