MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; TTL1LYR 16FR10ML 100%SILI UM TRAY

Catalog Number	URO170816
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/30/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that the tip of the syringe used to inflate the urinary catheter balloon broke off into the balloon inflation port.When this was identified, the urinary catheter balloon was deflated via an unidentified method.The urinary catheter was then removed and replaced with a new urinary catheter.No further incident or adverse patient effect was reported.No sample was returned to the manufacturer for evaluation.A root cause for the reported incident could not be determined.Due to the reported need for medical intervention to remove and 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 a syringe tip broke off into the urinary catheter's balloon inflation port.

• Common Device Name: TTL1LYR 16FR10ML 100%SILI UM TRAY
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093 2753
• MDR Report Key: 8743848
• Report Number: 1417592-2019-00092
• Device Sequence Number: 19314197
• Product Code: OHR
• UDI-Device Identifier: 10888277862623
• UDI-Public: 10888277862623
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 06/28/2019

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: URO170816
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/07/2019
• Initial Report FDA Received Date: 06/28/2019
• 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: 64 YR
• Patient Weight: 104