MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION EFFLUENT SAMPLE BAG; SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

Catalog Number	5C4476
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/05/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that 3 effluent sample bags were leaking near the port where medications are added.The customer reported that they went through three bags trying to collect an effluent sample and each one leaked near the port where medication is added.Additionally, it was reported that it appeared that the plastic on the bag was not sealed resulting in the leaks.The leaks were discovered during peritoneal dialysis (pd) therapy.There was no patient injury or medical intervention associated with this event.No additional information is available.
Additional Manufacturer Narrative
Additional information: h3, h6.H10: the actual devices were discarded; however, one (1) companion sample was received for evaluation.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.Functional testing including leak, clear passage, and clamp function testing were performed with no issues noted.The reported condition was not verified.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 SAMPLE BAG
• Common Device Name: SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 11637703
• Report Number: 1416980-2021-01992
• Device Sequence Number: 14301952
• Product Code: KDJ
• UDI-Device Identifier: 00085412007717
• UDI-Public: (01)00085412007717
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K923065
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/11/2021

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 06/08/2025
• Device Catalogue Number: 5C4476
• Device Lot Number: H20F08063
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/15/2021
• Supplement Date Received by Manufacturer: 05/07/2021
• Initial Report FDA Received Date: 04/08/2021
• Supplement Report FDA Received Date: 05/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1