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
Additional Manufacturer Narrative
B3.Date of event: unknown.No information has been provided to date.H3.Reason device not evaluated by mfg: other; device was not returned to manufacturer.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
Event or Problem Description
It was reported that the tubing was cracked, resulting in air in the line and leakage. there was unknown patient involvement and unknown patient harm/adverse event reported.
Additional Manufacturer Narrative
Corrected : d3 - mfg establishment name and g1 - contact office establishment name 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.

• 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: 21573499
• Report Number: 1526863-2025-00014
• Device Sequence Number: 8347134
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• 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?: Yes
• Date Returned to Manufacturer: 02/20/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/14/2025
• Supplement Date Received by Manufacturer: 05/30/2025
• Initial Report FDA Received Date: 03/11/2025
• Supplement 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