MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; TRAY, 1LYR 6FR 3ML100%SIL TEMP URN MTR

Catalog Number	URO170806T
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that the urinary catheter balloon burst after being inflated with 3ml of fluid.The urinary catheter was replaced.When the 2nd urinary catheter balloon was inflated with 3ml of fluid, it burst as well.A 3rd urinary catheter was inserted and only inflated with 1.5ml of fluid and no bursting was noted.According to reporting facility, no pieces of the urinary catheter were retained in the patient following the reported bursting.No adverse patient impact was reported to the manufacturer.No sample was returned to the manufacturer for evaluation.A root cause for the reported incident was unable to be determined.Due to the reported need for medical intervention to replace the 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 burst after inflation.

• Common Device Name: TRAY, 1LYR 6FR 3ML100%SIL TEMP URN MTR
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield, il
• MDR Report Key: 9780696
• Report Number: 1417592-2020-00014
• Device Sequence Number: 561253
• Product Code: EZL
• UDI-Device Identifier: 10889942929160
• UDI-Public: 10889942929160
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/03/2020

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 Catalogue Number: URO170806T
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/12/2020
• Initial Report FDA Received Date: 03/03/2020
• 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