MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP Medline; CATHETER,FOLEY,100%SILICONE,12FR,10ML,LF

Model Number	DYND11500
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/16/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the customer, a foley "broke inside of the patient while in use".
Additional Manufacturer Narrative
According to the customer, a foley "broke inside of the patient while in use".The customer reported they are unable to provide additional details related to the reported incident because they "do not have the information." the customer is requesting a replacement.The customer reported sample is not available to be returned.No additional information is available at this time.It has been determined that the reported event could cause or contribute to serious injury if it were to occur again.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
• Common Device Name: CATHETER,FOLEY,100%SILICONE,12FR,10ML,LF
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: danielle tognocchi ; three lakes drive; northfield, IL 60093
• MDR Report Key: 16537674
• Report Number: 1417592-2023-00099
• Device Sequence Number: 12384772
• Product Code: EZL
• UDI-Device Identifier: 10080196801220
• UDI-Public: 10080196801220
• Combination Product (Y/N): N
• Initial Reporter State: NV
• 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): 03/14/2023

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 Model Number: DYND11500
• Device Catalogue Number: DYND11500H
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/16/2023
• Initial Report FDA Received Date: 03/14/2023
• 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