MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION INTERLINK SYSTEM; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	2C6401
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that an interlink system solution set was leaking from the middle of the tubing.The leak was further described as a slow drip from the middle of the tubing when under pressure from an unspecified infusion pump.This was observed during use.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
Additional Manufacturer Narrative
Date of event/device available for evaluation: this event occurred between november 2022 to december 2022.Should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
Correction b5: change to an unspecified quantity of interlink system solution sets were leaking; ¿at least 3 incidents¿ (quantity reported as one on initial).H10: a batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The device was not received for evaluation; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: INTERLINK SYSTEM
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE - SINGAPORE; 2 woodlands industrial park d; singapore 73875 0; SN 738750
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 16205828
• Report Number: 1416980-2022-07447
• Device Sequence Number: 14859706
• Product Code: FPA
• UDI-Device Identifier: 00085412002118
• UDI-Public: (01)00085412002118
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K123868
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/13/2023

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
• Operator of Device: Health Professional
• Device Catalogue Number: 2C6401
• Device Lot Number: SR21H21082
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/27/2022
• Supplement Date Received by Manufacturer: 01/19/2023
• Initial Report FDA Received Date: 01/19/2023
• Supplement Report FDA Received Date: 02/13/2023
• 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: UNSPECIFIED INFUSION PUMP
• Patient Sex: Unknown