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

Model Number	DYND11519
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that the urinary catheter balloon leaked during inflation.The clinician was unable to inflate the urinary catheter balloon and the device slid out of the patient.A new urinary catheter was inserted without further incident.According to the reporting facility, there was no adverse impact to the patient related to the reported urinary catheter balloon issue.No sample was returned to the manufacturer for evaluation.A root cause was unable to be determined.Due to the reported need for medical intervention to insert a new urinary catheter, 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 leaked during inflation.

• Brand Name: Medline
• Common Device Name: TRAY,FOLEY,100% SILICONE,16FR,10ML,LF
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield, il
• MDR Report Key: 9865716
• Report Number: 1417592-2020-00031
• Device Sequence Number: 2827785
• Product Code: EZL
• UDI-Device Identifier: 10080196809790
• UDI-Public: 10080196809790
• Combination Product (Y/N): N
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 03/23/2020

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
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/27/2020
• Initial Report FDA Received Date: 03/23/2020
• 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 Age: 80 YR
• Patient Weight: 50