MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; CATHETER,FOLEY,COUDE,LATEX,16FR,10ML

Catalog Number	DYND11216H
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/31/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that the foley catheter was leaking and occluded.The location of the leakage was not identified.Reportedly, irrigation was attempted but was unable to be performed.The foley catheter was reportedly in place for four (4) days prior to the reported product issue.The patient went to a local hospital emergency department (ed) where the foley catheter was reportedly removed and a new foley catheter was inserted.No ed diagnostics, additional medical intervention, hospital admission, or follow-up care was reported to the manufacturer.No impact to the patient's stability or the patient's plan of care was reported to the manufacturer.Reportedly, the foley catheter was discarded after removal and no sample was returned to the manufacturer for evaluation.A root cause could not be determined.Due to the need for medical intervention to insert a new foley catheter, 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 that the foley catheter was leaking and occluded.The foley catheter was removed and a new foley catheter was inserted.

• Common Device Name: CATHETER,FOLEY,COUDE,LATEX,16FR,10ML
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093 2753
• MDR Report Key: 7742656
• Report Number: 1417592-2018-00081
• Device Sequence Number: 19173675
• Product Code: EZL
• UDI-Device Identifier: 10080196726769
• UDI-Public: 10080196726769
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/02/2018

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: Health Professional
• Device Catalogue Number: DYND11216H
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/01/2018
• Initial Report FDA Received Date: 08/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Weight: 63