MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; CATHETER,FOLEY,3-WAY,20FR,30ML,100%SILI

Catalog Number	DYND11574
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/10/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the customer, on (b)(6) 2023 the catheter that was placed on (b)(6) 2023 came out with the balloon "ruptured".The customer reported the catheter was a "20fr 30ml balloon catheter".The customer reported the catheter was replaced with a "18fr 10ml balloon catheter".The customer did not report any serious injury, medical intervention/attention, or follow up care related to the reported incident.Sample requested for return evaluation.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, on (b)(6) 2023 the catheter that was placed on (b)(6) 2023 came out with the balloon "ruptured".

• Common Device Name: CATHETER,FOLEY,3-WAY,20FR,30ML,100%SILI
• 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: 18093788
• Report Number: 1417592-2023-00443
• Device Sequence Number: 6753958
• Product Code: EZL
• UDI-Device Identifier: 10884389119525
• UDI-Public: 10884389119525
• 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): 11/08/2023

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 Catalogue Number: DYND11574
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/10/2023
• Initial Report FDA Received Date: 11/08/2023
• 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