MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION EFFLUENT SAMPLE BAG; SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

Catalog Number	5C4476
Medical Device Problem Codes	Break (1069); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/25/2022
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 an effluent sample bag leaked.The bag was not sealed causing a leak at the "medication" port.This occurred during a product demonstration.There were no signs of physical damage to the product or shipping materials.There was no patient involvement.No additional information is available.
Additional Manufacturer Narrative
H10: one actual sample was received for evaluation.A visual inspection with the naked eye and magnification noted a channel the near port seal area.Functional testing including clear passage and clamp function testing were performed no issues noted; leak testing identified a channel leak on the outer side of the port at the radio frequency (rf) weld.The reported condition was verified.The cause of the condition is related to inadequate solvent application during manufacturing.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: SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE - MOUNTAIN HOME; 1900 n highway 201; mountain home AR 72653
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL ; 2242702068
• MDR Report Key: 14738226
• Report Number: 1416980-2022-03178
• Device Sequence Number: 19399186
• Product Code: FKX
• UDI-Device Identifier: 00085412007717
• UDI-Public: (01)00085412007717
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/15/2022

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: Other
• Device Expiration Date: 10/19/2025
• Device Catalogue Number: 5C4476
• Device Lot Number: H20J19048
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/25/2022
• Supplement Date Received by Manufacturer: 06/29/2022
• Initial Report FDA Received Date: 06/17/2022
• Supplement Report FDA Received Date: 07/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/19/2020
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NA.
• Patient Sex: Unknown