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

Model Number	7N8399
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: initial reporter phone no.: (b)(6).Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that an unspecified quantity of needle-free iv connectors had a damaged overpouch.This was observed before product use.The event was further described as "peel pack paper on the front of the product is very thin and fragile causing it to break off and crumple.Looks like a hard boiled egg." the packaging looked as if it was "missing the membrane that goes on the back side of the front cover causing it to disintegrate".There was no patient involvement.No additional information is available.
Additional Manufacturer Narrative
Additional information was added to h4, h6, and h11: 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: ONE-LINK
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; 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: 22445277
• Report Number: 1416980-2025-03673
• Device Sequence Number: 15532555
• Product Code: FPA
• UDI-Device Identifier: 00085412091785
• UDI-Public: (01)00085412091785(10)UR19C10051
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K132734
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/07/2025

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: 7N8399
• Device Catalogue Number: 7N8399
• Device Lot Number: UR19C10051
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/10/2025
• Supplement Date Received by Manufacturer: 07/25/2025
• Initial Report FDA Received Date: 07/08/2025
• Supplement Report FDA Received Date: 08/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/11/2019
• 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: NA.
• Patient Sex: Unknown