MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX ABG-LINE DRAW 3ML; TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION

Catalog Number	G1469J
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 when blood gas was drawn, there was blood leaking out of the device.Another pro-vent plus arterial blood sampling kit device was used.There was no disinfection or sterilization, and no infectious diseases occurred.There were no patient harm or adverse event reported as a result of the event.
Additional Manufacturer Narrative
G1: corrected.H6: evaluation codes updated.Device evaluation: one sample was received.A visual inspection found that there was a crack along the syringe barrel shoulder.Testing was not conducted as the evident crack would cause leakage to occur.Dhr information for this lot indicated that the product met established acceptance requirements.The machine maintenance logbook was checked for entries made on the date of manufacture that would pertain to these issues.None were found.The complaint was confirmed.A quality alert was issued to production to heighten awareness to this potential issue.Complaint information will continue to be monitored for any new information and further actions will be taken accordingly.

• Brand Name: PORTEX ABG-LINE DRAW 3ML
• Common Device Name: TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 10 bowman dr; keene NH 03431
• Manufacturer Contact: reed covert ; 10 bowman dr; keene, NH 03431 ; 2247062300
• MDR Report Key: 21376026
• Report Number: 1217052-2025-00041
• Device Sequence Number: 19775952
• Product Code: JKA
• UDI-Device Identifier: 00351688060238
• UDI-Public: (01)00351688060238(17)270603(10)6020317
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K952516
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/28/2025

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: G1469J
• Device Lot Number: 6020317
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/03/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/24/2025
• Supplement Date Received by Manufacturer: 03/07/2025
• Initial Report FDA Received Date: 02/13/2025
• Supplement Report FDA Received Date: 03/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/10/2024
• 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