MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC. MEDLINE; TRAY,FOLEY,CATH,SIL-ELAST,16FR,10ML,BG

Model Number	DYND11003
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/06/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that the urinary catheter leaked.The urinary catheter was inserted on (b)(6) 2021 and, at the end of the day, the patient complained of leakage.When the urinary catheter was assessed, it was reportedly found that only 5ml of fluid remained in the urinary catheter balloon.The urinary catheter was removed and replaced without further reported incident.Despite multiple good faith attempts, the reporting facility was unable or unwilling to provide additional information beyond what was originally reported.No adverse patient impact was originally reported and no sample has been returned to the manufacturer.A root cause for the reported incident could not be determined at this time.Due to the reported need for medical intervention to remove and replace the urinary 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 urinary catheter leaked.

• Brand Name: MEDLINE
• Common Device Name: TRAY,FOLEY,CATH,SIL-ELAST,16FR,10ML,BG
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093 2753
• MDR Report Key: 12298825
• Report Number: 1417592-2021-00140
• Device Sequence Number: 19837285
• Product Code: OHR
• UDI-Device Identifier: 10080196991471
• UDI-Public: 10080196991471
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: DYND11003
• Device Catalogue Number: DYND11003H
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/15/2021
• Initial Report FDA Received Date: 08/09/2021
• 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