MAUDE Adverse Event Report: SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. MEDEX TRANSTAR BLOOD SAMPLE KIDS KIT; ARTERIAL BLOOD SAMPLING KIT

Catalog Number	MX9543
Medical Device Problem Codes	Crack (1135); Fluid/Blood Leak (1250); Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The device was returned because the transtar@ kids kit 19in closed blood sample kit 10/ca tubing was cracked.During the physical inspection, air in the line and leakage were observed.Patient involvement is unknown, and no patient harm or adverse event has been reported.
Additional Manufacturer Narrative
Thirty-nine (39) unused devices were effect and two devices were tested for evaluation.The tubing was cracked resulting in air in the line and leaked (air line/leaking) was confirmed through the device analysis, since 2 out of 35 returned samples leaked.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.Mrn reference number: 1526863-2025-00014.

• Brand Name: MEDEX TRANSTAR BLOOD SAMPLE KIDS KIT
• Common Device Name: ARTERIAL BLOOD SAMPLING KIT
• Manufacturer (Section D): SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V.; carretera miguel alemán km21.7; apodaca nuevo leon ; MX
• Manufacturer Contact: reed covert ; 6250 shier rings road; dublin, OH 43016 ; 2247062300
• MDR Report Key: 22301780
• Report Number: 1526863-2025-00071
• Device Sequence Number: 18299773
• Product Code: CBT
• UDI-Device Identifier: 10351688503091
• UDI-Public: (01)10351688503091(17)271028(10)6053188
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K070340
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 06/20/2025

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: Health Professional
• Device Catalogue Number: MX9543
• Device Lot Number: 6053188
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/30/2025
• Initial Report FDA Received Date: 06/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/30/2024
• 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