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

Model Number	204821
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	12/10/2019
Type of Reportable Event	Malfunction
Event or Problem Description
The clinic stated that during setup, "particles" were observed in several ipr 150 medication reservoirs after opening the bag and also filling.No medical intervention or injury reported.Product was misplaced at the facility and therefore will not be returned for investigation.This is a first time occurrence for this issue for this product.

• Brand Name: WALKMED
• Common Device Name: RESERVOIR BAG
• Manufacturer (Section D): WALKMED, LLC; 14190 east jewell ave; unit 10; aurora CO 80012
• MDR Report Key: 9597933
• Report Number: 3000204189-2020-00001
• Device Sequence Number: 352761
• Product Code: FPA
• UDI-Device Identifier: 00859695006053
• UDI-Public: (01)00859695006053(17)231025(10)21018511
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K870524
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/15/2020

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 Expiration Date: 10/25/2023
• Device Model Number: 204821
• Device Catalogue Number: 204821
• Device Lot Number: 21018511
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/18/2019
• Initial Report FDA Received Date: 01/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other