MAUDE Adverse Event Report: BAXTER INTERNATIONAL INC. INTERLINK; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	2N3339
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Puncture/Hole (1504)
Health Effect - Clinical Codes	Hypoglycemia (1912); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	10/13/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported an interlink system non-dehp t-connector extension set leaked due to a hole in the line.During patient infusion with total parenteral nutrition (tpn) and lipids via peripherally inserted central catheter (picc) line, blood was observed "backing out of the picc line and seeping out of the t-connector".The leak occurred for an unknown amount of time.The nurse then checked the patient¿s blood sugar, and it was found to be "28" with patient "alert and active".An intravenous line was attempted, and the t-connector was changed.The picc line was flushed with no leaks noted and good blood return.D10 bolus was initiated through the picc line and oral gel glucose administered.No further information was available at the time of this report.
Additional Manufacturer Narrative
D4: lot #: reported non-valid lot numbers: 8900-0223-01 and 8900-000219-0.Should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
Additional information: b3, h6 and h11.B3: event date: was updated to 10/13/2024.H11: the device was not returned and the lot number(s) that were reported were invalid; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: INTERLINK
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER INTERNATIONAL INC.; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE - AIBONITO; rd 721 km 0 3 po box 1389; aibonito 00705
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 20659406
• Report Number: 1416980-2024-06464
• Device Sequence Number: 8237142
• Product Code: FPA
• UDI-Device Identifier: 00085412004747
• UDI-Public: (01)00085412004747
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K921899
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/07/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 2N3339
• Device Catalogue Number: 2N3339
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/15/2024
• Supplement Date Received by Manufacturer: 12/24/2024
• Initial Report FDA Received Date: 11/11/2024
• Supplement Report FDA Received Date: 01/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: LIPIDS; PERIPHERALLY INSERTED CENTRAL CATHETER; TOTAL PARENTERAL NUTRITION
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown