MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. MEDLINE; CATHETER CARE TRAY

Model Number URO170816TS

Patient Problem Insufficient Information (4580)

Event Date 10/23/2023

Event Type  malfunction  

Event Description

During surgical procedure, scrub tech noticed that the 16fr.Foley placed by surgeon was out of the patient and on the floor.Second foley opened and placed.First foley examined.Balloon inflated with syringe of nss.No hole or evidence of a leak was noted.Circulator stretched the foley with light tension, and immediately a leak was noted in tubing of foley, and the balloon began to deflate.Pinprick hole noted and demarcated with sharpie, approximately two inches from the proximal edge of the balloon.Name of product: total one layer tray selectsilicone temperature sensing 100% silicone foley catheter tray pre-connected to urine meter 16fr 10ml.Manufactured by medline industries.Ref# of product: uro170816ts, gtin#: (b)(4), lot#: (10)23hbm627.Expiration [redacted date].

• Brand Name: MEDLINE
• Type of Device: CATHETER CARE TRAY
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 18028637
• MDR Text Key: 326833885
• Report Number: 18028637
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: URO170816TS
• Device Catalogue Number: URO170816TS
• Device Lot Number: 23HBM627
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/23/2023
• Event Location: Hospital
• Date Report to Manufacturer: 10/30/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1