MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; CATHETER,URETHRAL,REDRUBBER,STERILE,8FR

Catalog Number	DYND13508
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/01/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that the urethral catheter was being used to maintain tracheostomy stoma patency.Reportedly, the device became lodged in the patient's left bronchus and an unidentified procedure was required to remove the urethral catheter.After multiple good-faith attempts, the facility contact was unable or unwilling to provide additional patient, product, or procedural information related to this incident.It was not identified how long the urethral catheter was in use for.It was not identified how the urethral catheter was secured to the tracheostomy stoma.No additional information related to this incident was reported to the manufacturer.No sample was returned to the manufacturer for evaluation.The reported use of the urethral catheter to maintain tracheostomy stoma patency is off-label use.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 urethral catheter was being used to maintain tracheostomy stoma patency.Reportedly, the device became lodged in the patient's left bronchus and an unidentified procedure was required to remove the urethral catheter.

• Common Device Name: CATHETER,URETHRAL,REDRUBBER,STERILE,8FR
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093 2753
• MDR Report Key: 7697751
• Report Number: 1417592-2018-00061
• Device Sequence Number: 1040357
• Product Code: EYB
• UDI-Device Identifier: 10080196031139
• UDI-Public: 10080196031139
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: DYND13508
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/26/2018
• Initial Report FDA Received Date: 07/18/2018
• 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