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

Model Number URO170518S

Device Problems Break (1069); Inflation Problem (1310)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/13/2022

Event Type  malfunction  

Event Description

Tip of syringe broke off when attempting to inflate foley balloon.

• Brand Name: MEDLINE
• Type of Device: CATHETER CARE TRAY
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; one medline place; mundelein IL 60060
• MDR Report Key: 15592573
• MDR Text Key: 301735925
• Report Number: 15592573
• 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: 09/28/2022,09/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: URO170518S
• Device Catalogue Number: URO170518S
• Device Lot Number: 21VBB183
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/28/2022
• Date Report to Manufacturer: 10/05/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female