MAUDE Adverse Event Report: BAXTER HEALTHCARE - BROOKLYN PARK EFFLUENT BAG; SYSTEM, HEMODIALYSIS, REMOTE ACCESSORIES

Catalog Number	114423
Medical Device Problem Codes	Disconnection (1171); Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/31/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
The customer observed a leakage from the connection port of a 5l effluent drain bag during use.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
Additional Manufacturer Narrative
The device was manufactured in june 2017.The device was received for evaluation in an open pouch.Visual inspection revealed that the yellow valve handle was detached from the white valve body.There was visible deformation of the yellow valve handle and color transfer on the white valve body which points to the valve handle being closed with enough force to pop the handle off.The reported condition was verified.The cause of the condition was not determined.A nonconformance has been opened to address this issue.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: EFFLUENT BAG
• Common Device Name: SYSTEM, HEMODIALYSIS, REMOTE ACCESSORIES
• Manufacturer (Section D): BAXTER HEALTHCARE - BROOKLYN PARK; minneapolis MN
• MDR Report Key: 7300459
• Report Number: 3003504604-2018-00001
• Device Sequence Number: 16623788
• Product Code: MON
• UDI-Device Identifier: 07332414112264
• UDI-Public: (01)07332414112264
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/03/2018

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: 06/05/2020
• Device Catalogue Number: 114423
• Device Lot Number: A3152
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2018
• Initial Date Received by Manufacturer: 01/31/2018
• Supplement Date Received by Manufacturer: 03/16/2018
• Initial Report FDA Received Date: 02/27/2018
• Supplement Report FDA Received Date: 04/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1