MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION REVACLEAR 300; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number 114748

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Patient Involvement (2645)

Event Date 11/23/2020

Event Type  malfunction  

Manufacturer Narrative

Phone number: (b)(6).Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that a particulate matter was observed inside the cap of one unit of revaclear 300 before patient use.There was no patient involvement.No additional information is available.

Manufacturer Narrative

H10: a batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The device was not received for evaluation; however visual inspection of two provided photos showed the product dry and with one brownish particle observed on the header cap.The reported condition was verified.The second photo showed the product label.The most likely cause is a slip in the visual inspection.During the manufacturing process.A nonconformance has been opened to address this issue.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: REVACLEAR 300
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 11035499
• MDR Text Key: 222401152
• Report Number: 9611369-2020-00189
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 07332414114947
• UDI-Public: (01)07332414114947
• Combination Product (y/n): Y
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/19/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2023
• Device Catalogue Number: 114748
• Device Lot Number: 0-9626-H-01
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/24/2020
• Initial Date FDA Received: 12/18/2020
• Supplement Dates Manufacturer Received: 01/15/2021
• Supplement Dates FDA Received: 01/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1