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

Catalog Number DYND13508

Device Problem Off-Label Use (1494)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/01/2018

Event Type  Injury  

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 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.

• Type of Device: CATHETER,URETHRAL,REDRUBBER,STERILE,8FR
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: nigel vilches ; three lakes drive; northfield, IL 60093-2753 ; 2249311458
• MDR Report Key: 7697751
• MDR Text Key: 114292021
• Report Number: 1417592-2018-00061
• Device Sequence Number: 1
• Product Code: EYB
• UDI-Device Identifier: 10080196031139
• UDI-Public: 10080196031139
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: DYND13508
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/26/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention