MAUDE Adverse Event Report: BAXTER INTERNATIONAL INC. ONE-LINK; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	7N8377
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/09/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that an one-link non-dehp y-type standard bore catheter extension set had a separation of the tubing from the y-junction.The event was further described as, "iv came apart at the junction of the pigtail where it goes from 1 to 2 tubes".This was observed during an unspecified process step.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
Additional Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
H11: the actual sample and photographs of the sample were received for evaluation.A visual inspection was performed, and it was noted that y junction came apart from the tubing.The returned photographs were reviewed, and it was also noted that the y junction came apart from the tubing.The reported condition as verified.The cause of the reported condition was a manufacturing issue.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: ONE-LINK
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER INTERNATIONAL INC.; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE - DOMINICAN REPUBLIC; carretera sanchez km 18.5; parque industrial itabo, piisa; haina, san cristobal 91000 ; DR 91000
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 20267621
• Report Number: 1416980-2024-05138
• Device Sequence Number: 3393307
• Product Code: FPA
• UDI-Device Identifier: 00085412091808
• UDI-Public: (01)00085412091808(10)DR24D08024
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/07/2024

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: 7N8377
• Device Catalogue Number: 7N8377
• Device Lot Number: DR24D08024
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2024
• Supplement Date Received by Manufacturer: 10/25/2024
• Initial Report FDA Received Date: 09/20/2024
• Supplement Report FDA Received Date: 11/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/09/2024
• 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