MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION EFFLUENT BAG; SYSTEM, HEMODIALYSIS, REMOTE ACCESSORIES

Catalog Number	107650
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/07/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Phone number: (b)(6).Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that an external fluid leak was observed from a 9l effluent bag at the level of the weld, 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 actual device was not available; however, three companion samples were received for evaluation.A visual inspection and leak test were performed, and no issues were observed.The reported condition was not verified.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 CORPORATION; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE - MALTA; a47 industrial estate; marsa ; MT
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL ; 2242702068
• MDR Report Key: 13653326
• Report Number: 1416980-2022-00837
• Device Sequence Number: 20278813
• Product Code: MON
• UDI-Device Identifier: 07332414075828
• UDI-Public: (01)07332414075828
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 04/04/2022

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: 07/31/2022
• Device Catalogue Number: 107650
• Device Lot Number: 21H23V490
• 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: 02/09/2022
• Supplement Date Received by Manufacturer: 03/07/2022
• Initial Report FDA Received Date: 03/02/2022
• Supplement Report FDA Received Date: 04/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Patient Sex: Unknown