MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. TRAY CAUTI TEMP SENS 16FR 10ML; CATHETER CARE TRAY

Catalog Number URO180816TS

Device Problems Material Protrusion/Extrusion (2979); Output Problem (3005)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 12/31/2021

Event Type  malfunction  

Event Description

Rn (registered nurse) removed indwelling foley, removed and patient instantly started bleeding out of his urethra requiring pressure to be applied for approximately 10 minutes.Urology was consulted and coude catheter placed.The nurse reported, "upon looking at catheter, balloon plastic stuck out from catheter, causing a protrusion from the catheter, rather than smooth; therefore, causing trauma/injury upon removal.When inflating balloon post-removal, balloon hyper inflated on one side, which was the side the plastic stuck out from.Appeared as if inflation stretched plastic too much and plastic did not resume smooth finish for removal.Only 10 mls confirmed in foley balloon before removing.".

• Brand Name: TRAY CAUTI TEMP SENS 16FR 10ML
• Type of Device: CATHETER CARE TRAY
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; one medline pl; mundelein IL 60060
• MDR Report Key: 13235536
• MDR Text Key: 283678748
• Report Number: 13235536
• Device Sequence Number: 1
• Product Code: OHR
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 01/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: URO180816TS
• Device Lot Number: 21EBE543
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/05/2022
• Event Location: Hospital
• Date Report to Manufacturer: 01/12/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 18615 DA
• Patient Sex: Male
• Patient Weight: 20 KG