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

Catalog Number XMC4284

Device Problem Failure to Disconnect (2541)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/11/2023

Event Type  malfunction  

Event Description

It was reported that a drainage set had a connection issue; further described as ¿unable to disconnect drain bag from the transfer set¿.This occurred after treatment of peritoneal dialysis therapy, during disconnection.There was no report of patient injury; however, prophylactic antibiotics were administered.No additional information is available.

Manufacturer Narrative

E1: initial reporter address: (b)(6).Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

H4: the lot was manufactured in december 2022.H10: the actual device was not available; however, a photograph was provided and retention samples were evaluated.A visual inspection of the photograph was performed and the issue could not be identified by the photo.A visual inspection of the retention samples was performed with no issues noted.The retention samples were also gravity tested in the laboratory via methylene blue; then leak tested under water with no issues noted.The reported condition was not verified in the photograph or during evaluation of the retention samples.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: EMPTY STERILE CONTAINER
• Type of Device: SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE - TUNISIA; route de chebbaou; 2021oued e; tunis ; TS
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 17913880
• MDR Text Key: 325714557
• Report Number: 1416980-2023-05166
• Device Sequence Number: 1
• Product Code: KDJ
• UDI-Device Identifier: 05413760232317
• UDI-Public: (01)05413760232317
• Combination Product (y/n): N
• Reporter Country Code: EI
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 11/10/2023

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
• Device Operator: Lay User/Patient
• Device Catalogue Number: XMC4284
• Device Lot Number: 22K24T343
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/13/2023
• Initial Date FDA Received: 10/11/2023
• Supplement Dates Manufacturer Received: 11/06/2023
• Supplement Dates FDA Received: 11/10/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: MINICAP TRANSFER SET.
• Patient Sex: Male