MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION ONE-LINK; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	7N8390
Medical Device Problem Code	Protective Measures Problem (3015)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a syringe pump alarmed during the use of a one-link non-dehp microbore catheter extension set.The alarm was due to pressure in the set which delayed the medication delivery to the patient.This issue was identified during patient use.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
Additional Manufacturer Narrative
E1: initial reporter address: (b)(6) g1: manufacturer name: baxter healthcare - aibonito address line 1: (b)(6) us city or (foreign state/province/territory): (b)(6) us state (select from fda approved list): na us zip code (b)(6) or (b)(6) or foreign postal code (10 digits): (b)(6) country (select from fda approved list) (b)(6) g1: manufacturer name: baxter healthcare - cartago address line 1: 600 mts.Oeste de entrada, principal ave.Las americas, parque industrial us city or (foreign state/province/territory): cartago us state (select from fda approved list): na us zip code (55555) or (55555-4444) or foreign postal code (10 digits): 30106 country (select from fda approved list): costa rica should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
Correction made to d1 and d4: additional information was added to g4, h6, and h11: h11: the device was not returned, and the lot number is unknown; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: ONE-LINK
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE CORPORATION; ni; ni; ni
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 18136582
• Report Number: 1416980-2023-05924
• Device Sequence Number: 6560438
• Product Code: FPA
• UDI-Device Identifier: 00085412475417
• UDI-Public: (01)00085412475417
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K132734
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/30/2024

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 Model Number: 7N8390
• Device Catalogue Number: 7N8390
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 10/03/2024
• Initial Report FDA Received Date: 11/14/2023
• Supplement Report FDA Received Date: 10/30/2024
• 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
• Patient Sex: Unknown