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

Catalog Number	5C4480C
Medical Device Problem Code	Improper Flow or Infusion (2954)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The events occurred on unspecified dates, "recently".Initial reporter address: (b)(6).Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that air bubbles were observed in an unspecified quantity of patient extension sets.It was further specified that "once the solution passed the connection part of the extension set, bubbles appeared." the extension sets were tightly connected.This occurred during use of the devices for peritoneal dialysis therapy.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
Additional Manufacturer Narrative
H10: the device was received for evaluation.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.Functional testing including leak and clear passage 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: EXTENSION SET
• Common Device Name: SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 11426637
• Report Number: 1416980-2021-01086
• Device Sequence Number: 3243348
• Product Code: KDJ
• UDI-Device Identifier: 00085412087382
• UDI-Public: (01)00085412087382
• Combination Product (Y/N): Y
• Initial Reporter Country: CA
• PMA/510(K) Number: K925403
• 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): 03/18/2021

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: 11/04/2022
• Device Catalogue Number: 5C4480C
• Device Lot Number: H20K04022
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2021
• Initial Date Received by Manufacturer: 02/11/2021
• Supplement Date Received by Manufacturer: 03/16/2021
• Initial Report FDA Received Date: 03/07/2021
• Supplement Report FDA Received Date: 03/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NI.