MAUDE Adverse Event Report: BAXTER INTERNATIONAL INC. VIAL-MATE; SET, I.V. FLUID TRANSFER

Model Number	2B8071
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D4: unique identifier (udi) #: the lot number (10) is unknown; therefore, the udi number only will contain the device identifier (01).E1: initial reporter address: (b)(6).Mail code (b)(6) should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that two (2) vial-mate adapter leaked ¿when pulled up fully and locked¿.The event occurred during an unknown process step.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
Additional Manufacturer Narrative
Additional information: a1, b5, b6, b7, d4, f10/h6: health effect - impact codes, h3, h6 and h11.B3: event date: upon additional information one event occurred on 06/13/2024 and the other occurred on 07/29/2024.B5: upon additional information, the event occurred during set up.There was no patient involvement.D4: lot #: potential lot number: reported as ¿lot number was gr24024017 stocked currently¿.H11: two devices were received for evaluation.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.A functional test was performed on one (1) of the samples, and the device was properly activated per activation instructions and no leaks were observed.The second device could not be functionally tested as an iv (intravenous) bag stopper was jammed and broken off in the device.The reported condition was not verified.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: VIAL-MATE
• Common Device Name: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): BAXTER INTERNATIONAL INC.; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE - CLEVELAND; 911 highway 61 north; po box 1058; cleveland MS 38732
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 20075795
• Report Number: 1416980-2024-04544
• Device Sequence Number: 14221869
• Product Code: LHI
• UDI-Device Identifier: 00085412027388
• UDI-Public: (01)00085412027388
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K142600
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/31/2024

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: 2B8071
• Device Catalogue Number: 2B8071
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/31/2024
• Supplement Date Received by Manufacturer: 10/02/2024
• Initial Report FDA Received Date: 08/27/2024
• Supplement Report FDA Received Date: 10/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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