MAUDE Adverse Event Report: WALKMED, LLC WALKMED®; BAG, RESERVOIR

Model Number	204822
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/31/2023
Type of Reportable Event	Malfunction
Event or Problem Description
From details in this event report, the slit in tubing was likely a puncture, not defected product.Unsure of exact product used, but this is the product on hand information: bag = ref: 21-7059-24 lot 4372852.Set = ref: 204822 lot 20322508.

• Brand Name: WALKMED®
• Common Device Name: BAG, RESERVOIR
• Manufacturer (Section D): WALKMED, LLC; 14190 east jewell ave unit 10; aurora CO 80012
• MDR Report Key: 18484510
• Report Number: 18484510
• Device Sequence Number: 19513803
• Product Code: BTC
• UDI-Device Identifier: 00859695006060
• UDI-Public: (01)00859695006060
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 08/16/2023
• Report Date (Section F): 08/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 204822
• Device Catalogue Number: IPR-250
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 01/10/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/10/2024
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male
• Date Report Sent to FDA: 08/16/2023