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

Model Number	2N8399
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/24/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a clearlink luer activated valve disconnected from a syringe filled with rho(d) immune globulin.The disconnection occurred during patient administration via an intravenous (iv) push.When the nurse pushed on the syringe, the valve twisted and fell off.There was no report of patient injury; however, the medication was given intramuscularly.No additional information is available.
Additional Manufacturer Narrative
E1: initial reporter address: (b)(6).Should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
Additional information was added to h6 and h11: h11: the actual device was not available; however, a companion sample was received for evaluation.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.A pressure test was performed, and no leaks were observed.The companion sample was connected to an in-lab syringe and t joint, and no loose connections were observed.The reported condition was not verified.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: CLEARLINK
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER INTERNATIONAL INC.; 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: 20031605
• Report Number: 1416980-2024-04410
• Device Sequence Number: 3023853
• Product Code: FPA
• UDI-Device Identifier: 00085412048895
• UDI-Public: (01)00085412048895(10)SR23H25005
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K112893
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/19/2024

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: Health Professional
• Device Model Number: 2N8399
• Device Catalogue Number: 2N8399
• Device Lot Number: SR23H25005
• 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: 07/25/2024
• Supplement Date Received by Manufacturer: 09/12/2024
• Initial Report FDA Received Date: 08/22/2024
• Supplement Report FDA Received Date: 09/19/2024
• 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: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: RHO(D) IMMUNE GLOBULIN (RHOPHYLAC).; UNSPECIFIED SYRINGE.
• Patient Sex: Unknown