MAUDE Adverse Event Report: WALKMED, LLC WALKMED LLC; 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	05/20/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Clinic reported "i found another particle, of the same sort that i described in december, in a pump bag that i was checking." (in reference to additional complaint reported on 3000204189-2020-00001) she also reported "of course, fluorouracil does crystalize, so it's possible it could be a drug particle, but i check the vials and the tech double checks them for any crystallization before mixing and we didn't see any after drug had been put in.I don't think it would have been likely to see it before mixing, because it is tiny and white to translucent.I don't think it's a fluorouracil crystal though, because those sink in the fluorouracil solution and this particle floats." bag was disposed of after identifying the particulate.Additional bags from this lot were sent to walkmed for review and no additional particulate was identifying during testing.No internal non-conforming reports or additional customer related complaints have ever been identified for particulate.

• Brand Name: WALKMED LLC
• Common Device Name: RESERVOIR BAG
• Manufacturer (Section D): WALKMED, LLC; 14190 east jewell ave; unit 10; aurora, co
• MDR Report Key: 10171202
• Report Number: 3000204189-2020-00003
• Device Sequence Number: 16585008
• Product Code: FPA
• UDI-Device Identifier: 00859695006053
• UDI-Public: (01)00859695006053(17)241204(10)21219500
• Combination Product (Y/N): N
• 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): 06/15/2020

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: 12/04/2024
• 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: 05/20/2020
• Initial Report FDA Received Date: 06/18/2020
• 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