MAUDE Adverse Event Report: WALKMED TECHNOLOGIES WALKMED; RESERVOIR BAG

Model Number	IPR 150
Medical Device Problem Code	Precipitate in Device or Device Ingredient (1478)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/09/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Facility called hotline to report that they have a bag with "particles" in it.No pictures were provided and bag was disposed of so could not be returned.The rest of the bags in that lot have been isolated and put to the side, walkmed requested these bags and has recieved them.There was no patient impact since the particulate was identified in the bag during setup.
Additional Manufacturer Narrative
Only 2 bags remained in the lot for return, both bags where inspect by walkmed and no particulate was found.Additionally there is no remaining material of this lot at the walkmed facility for containment or investigation.The inspection and pictures of the 2 parts recieved are captured in the walkmed qms under capa 2226.

• Brand Name: WALKMED
• Common Device Name: RESERVOIR BAG
• Manufacturer (Section D): WALKMED TECHNOLOGIES; 14190 e. jewell ave; suite 10; aurora CO 80012
• Manufacturer (Section G): WALKMED TECHNOLOGIES; 14190 e. jewell ave; suite 10; aurora CO 80012
• Manufacturer Contact: thomas assante ; 14190 e. jewell ave; suite 10; aurora, CO 80012 ; 7203514944
• MDR Report Key: 18427805
• Report Number: 3000204189-2023-00001
• Device Sequence Number: 7743262
• Product Code: FPA
• UDI-Device Identifier: 10859695006050
• UDI-Public: (01)10859695006050(17)270819(10)20822500
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K870524
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date (Section B): 12/05/2023

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: IPR 150
• Device Catalogue Number: 204821
• Device Lot Number: 20622505
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/09/2023
• Initial Report FDA Received Date: 01/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/23/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown