MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP Medline; CATHETER,FOLEY,SILI-ELAST,LTX,18FR,10ML

Model Number	DYND11758
Health Effect - Clinical Code	Urinary Tract Infection (2120)
Date of Event	01/01/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported by the end-user that she is paralyzed from the waist down and has a suprapubic catheter.The end-user has been using catheters since she became paralyzed.The catheter was changed once a month until recently when she started changing every two weeks last month.There is still some irritation with the catheter.There has been bleeding around the site.The end user reported that she completed a round of antibiotics about two weeks ago for a urinary tract infection that she experienced from the catheter issue.3 companion samples were returned from the end-user to the manufacturer for evaluation.The reported issue of leaking foley catheter could not be confirmed through visual, functional or dimensional evaluation of all samples received.Due to the reported incident and in an abundance of caution, this medwatch is being filed.If additional relevant information becomes available a supplemental medwatch will be filed.
Event or Problem Description
It was reported by the end-user that the catheter is causing bleeding around the catheter site and urinary tract infections (utis).

• Brand Name: Medline
• Common Device Name: CATHETER,FOLEY,SILI-ELAST,LTX,18FR,10ML
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: karen trutsch ; three lakes drive; northfield, IL 60093
• MDR Report Key: 13049614
• Report Number: 1417592-2021-00222
• Device Sequence Number: 1608804
• Product Code: EZL
• UDI-Device Identifier: 10080196726530
• UDI-Public: 10080196726530
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/20/2021

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: DYND11758
• Device Catalogue Number: DYND11758
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/30/2021
• Initial Report FDA Received Date: 12/20/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (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: Required Intervention
• Patient Age: 41 YR
• Patient Sex: Female
• Patient Weight: 88 KG