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

Model Number	DYND11501
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/11/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the customer, the foley balloons are leaking and "catheters are falling out".The customer reported when balloons were assessed by filling the balloon with new fluid there was an "obvious leak or hole seen".The customer reported a new catheter was required to be inserted.There was no report of any serious injury or follow up care related to the reported incident.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.
Event or Problem Description
According to the customer, the foley balloons are leaking and "catheters are falling out".

• 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: danielle tognocchi ; three lakes drive; northfield, IL 60093
• MDR Report Key: 17347084
• Report Number: 1417592-2023-00302
• Device Sequence Number: 20561192
• Product Code: EZL
• UDI-Device Identifier: 10884389034439
• UDI-Public: 10884389034439
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 07/18/2023

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
• Operator of Device: Health Professional
• Device Model Number: DYND11501
• Device Catalogue Number: DYND11501
• Device Lot Number: 59222010045
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/26/2023
• Initial Report FDA Received Date: 07/18/2023
• 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