MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP; TRAY,ADD A CATH,FOLEY,DRAIN BAG,10ML SYR

Catalog Number DYND11020

Device Problem Infusion or Flow Problem (2964)

Patient Problem Insufficient Information (4580)

Event Date 01/01/2024

Event Type  malfunction  

Manufacturer Narrative

It was reported by the customer contact that "the urine does not go into the bag it is going back into the patient".Due to this, the catheter was removed and replaced.It has been determined that the reported event could cause or contribute to serious injury if it were to occur.In an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

Event Description

"the urine does not go into the bag it is going back into the patient".

• Type of Device: TRAY,ADD A CATH,FOLEY,DRAIN BAG,10ML SYR
• Manufacturer (Section D): MEDLINE INDUSTRIES LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: kelly zampella ; three lakes drive; northfield, IL 60093
• MDR Report Key: 18847734
• MDR Text Key: 337663536
• Report Number: 1417592-2024-00303
• Device Sequence Number: 1
• Product Code: OHR
• UDI-Device Identifier: 40080196998204
• UDI-Public: 40080196998204
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Catalogue Number: DYND11020
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/08/2024
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other