MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP; CATHETER,FOLEY,SILI-ELAST,LTX,16FR,30ML

Catalog Number	DYND11776
Medical Device Problem Codes	Inflation Problem (1310); Leak/Splash (1354)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/13/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the facility, every patient they have used this on has experienced leakage and the catheter balloon has not been staying inflated.
Additional Manufacturer Narrative
According to the facility, every patient they have used this on has experienced leakage and the catheter balloon has not been staying inflated.There was no further information.It has been determined that the reported event could cause or contribute to serious injury if it were to occur.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.

• Common Device Name: CATHETER,FOLEY,SILI-ELAST,LTX,16FR,30ML
• Manufacturer (Section D): MEDLINE INDUSTRIES LP; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: alex mathew ; three lakes drive; northfield, IL 60093-2753 ; 2244317042
• MDR Report Key: 20895279
• Report Number: 1417592-2024-01016
• Device Sequence Number: 7843169
• Product Code: EZL
• UDI-Device Identifier: 40080196726586
• UDI-Public: 40080196726586
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 12/10/2024

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: DYND11776
• Device Lot Number: 59224051370
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/13/2024
• Initial Report FDA Received Date: 12/10/2024
• 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