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

Catalog Number URO170816T

Device Problem Disconnection (1171)

Patient Problem No Code Available (3191)

Event Date 11/01/2019

Event Type  malfunction  

Manufacturer Narrative

It was reported that the urinary catheter disconnected from the tubing of the drainage bag.The disconnection was identified "immediately after" placing the urinary catheter.When the facility staff identified the issue, the urinary catheter was removed and a new urinary catheter was inserted with no further reported incident.No additional medical intervention or follow-up care was reported to the manufacturer.According to the reporting facility, the "yellow tape" at the connection site was unable to keep the urinary catheter secure to the tubing of the drainage bag.No sample was available to be 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 remove and replace the urinary catheter, this medwatch is being filed.If additional relevant information becomes available a supplemental medwatch will be filed.

Event Description

It was reported that the urinary catheter disconnected from the tubing of the drainage bag.

• Type of Device: TTL1LYR 16FR10ML 100%SIL TMP TRAY
• 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: 9401342
• MDR Text Key: 190032014
• Report Number: 1417592-2019-00213
• Device Sequence Number: 1
• Product Code: OHR
• UDI-Device Identifier: 10888277866942
• UDI-Public: 10888277866942
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: URO170816T
• Device Lot Number: 19FBD074
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/26/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 41 YR
• Patient Weight: 135