MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; CATHETER,FOLEY,SILVER,16FR,10ML,LF

Catalog Number DYND141016H

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Unspecified Infection (1930)

Event Date 03/20/2023

Event Type  Injury  

Manufacturer Narrative

According to the customer "the catheter was getting clogged which caused a fever, infection, and her son to be put on antibiotics".Per the customer "the catheter was a suprapubic catheter and urine was leaking from her son's penis and was described as dark and almost cola in appearance".Per the customer the catheter was replaced.No additional information is available at this time.The sample was requested for evaluation.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.

Event Description

According to the customer "the catheter was getting clogged which caused a fever, infection, and her son to be put on antibiotics".

• Type of Device: CATHETER,FOLEY,SILVER,16FR,10ML,LF
• 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: 16707790
• MDR Text Key: 312960224
• Report Number: 1417592-2023-00157
• Device Sequence Number: 1
• Product Code: EZL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/10/2023

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 Operator: Lay User/Patient
• Device Catalogue Number: DYND141016H
• Device Lot Number: (10)22KBH409
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/20/2023
• Initial Date FDA Received: 04/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other