MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC. MEDLINE; TRAY,FOLEY,100% SILICONE,18FR,10ML,LF

Model Number	DYND11520
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that the urinary catheter balloon would not inflate and the urinary catheter would not remain inserted.Despite multiple good faith attempts the original reporter was unable or unwilling to provide any additional information to the manufacturer.No adverse patient impact was originally reported to the manufacturer.No sample has been returned to the manufacturer for evaluation.A root cause for the reported incident was unable to be determined.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 that the urinary catheter balloon would not inflate.

• Brand Name: MEDLINE
• Common Device Name: TRAY,FOLEY,100% SILICONE,18FR,10ML,LF
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093 2753
• MDR Report Key: 11537099
• Report Number: 1417592-2021-00040
• Device Sequence Number: 4881992
• Product Code: OHR
• UDI-Device Identifier: 10080196997060
• UDI-Public: 10080196997060
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 03/21/2021

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: DYND11520
• Device Catalogue Number: DYND11520
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/01/2021
• Initial Report FDA Received Date: 03/22/2021
• 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: Other