MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. MEDLINE; TRAY,FOLEY,100% SILICONE,16FR,10ML,LF

Model Number	DYND11519
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/03/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported the foley catheter was leaking and required replacement.Additional information received by representative, (b)(6) health agency, who provided additional information related to this incident.Reporter states, the foley catheter placed/inserted in the patient (patient information not provided) on (b)(6) 2020.Reporter states the foley catheter balloon tested with 10cc of sterile water prior to insertion without issue noted at that time.Reporter states (b)(6) 2021, foley catheter was reported to be leaking by patient.Reporter states, after assessment the foley catheter was removed and replaced without incident.Reporter states, no serious injury or follow-up care was required.Reporter states no sample is available for return and evaluation.As a result, a root cause will be difficult to determine.Due to the reported incident, medical intervention and 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 or Problem Description
It was reported the foley catheter was leaking and required replacement.

• Brand Name: MEDLINE
• Common Device Name: TRAY,FOLEY,100% SILICONE,16FR,10ML,LF
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 11171582
• Report Number: 1417592-2021-00002
• Device Sequence Number: 16854374
• Product Code: OHR
• UDI-Device Identifier: 10080196809790
• UDI-Public: 10080196809790
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: consumer,health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 01/14/2021

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: DYND11519
• Device Catalogue Number: DYND11519H
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/05/2021
• Initial Report FDA Received Date: 01/14/2021
• 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