MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP; CATHETER,FOLEY,SILI-ELAST,LTX,24FR,10ML

Catalog Number	DYND11764
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	03/15/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the facility on 03/15/24 during a suprapubic catheter exchange the old catheter would not deflate.
Additional Manufacturer Narrative
According to the facility on 03/15/24 during a suprapubic catheter exchange the old catheter would not deflate.Per the facility the catheter remained anchored and could not be removed.Per the facility the resident was sent to their urologist for an emergency visit where they experienced a "moderate amount of bleeding due to trauma of removal".Per the facility the resident is well.The sample is not available for 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.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,24FR,10ML
• Manufacturer (Section D): MEDLINE INDUSTRIES LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: justin herrmann ; three lakes drive; northfield, IL 60093
• MDR Report Key: 19052296
• Report Number: 1417592-2024-00465
• Device Sequence Number: 7104568
• Product Code: EZL
• UDI-Device Identifier: 10080196726561
• UDI-Public: 10080196726561
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 04/05/2024

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: DYND11764
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/15/2024
• Initial Report FDA Received Date: 04/05/2024
• 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