MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; CATHETER,FOLEY,100%SILICONE,16FR,30ML,LF

Catalog Number	DYND11532
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/12/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Balloon ruptured.
Additional Manufacturer Narrative
It was reported that the balloon ruptured within two days of insertion.No additional information was provided by the customer contact.It has been determined that the reported event caused or contributed to serious injury, therefore, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

• Common Device Name: CATHETER,FOLEY,100%SILICONE,16FR,30ML,LF
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: kelly zampella ; three lakes drive; northfield, IL 60093
• MDR Report Key: 19073024
• Report Number: 1417592-2024-00476
• Device Sequence Number: 20546366
• Product Code: EZL
• UDI-Device Identifier: 40080196170983
• UDI-Public: 40080196170983
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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): 04/09/2024

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: DYND11532
• Device Lot Number: 59222081777
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/12/2024
• Initial Report FDA Received Date: 04/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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