MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX PRO-VENT 3ML ARTERIAL BLOOD SAMPLING; TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION

Catalog Number	G1467J
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3.Date of event: month and year of event have been provided, but day is unknown.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 filter pro leaked during patient use.There was patient involvement, and no patient harm/adverse event reported.
Additional Manufacturer Narrative
One device was received for investigation.The device was functionally tested, but the investigation could not duplicate the reported issue.The product's history records were reviewed and there were no non-conformances nor service-related issues that would have resulted in the reported complaint.The issue observed by the customer, could not be duplicated with the sample provided, therefore the complaint could not be confirmed.Complaint information will continue to be monitored for any new information or adverse trends and further actions will be taken accordingly.

• Brand Name: PORTEX PRO-VENT 3ML ARTERIAL BLOOD SAMPLING
• 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 ; 6000 nathan ln n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 21047428
• Report Number: 1217052-2024-00286
• Device Sequence Number: 8307239
• Product Code: JKA
• UDI-Device Identifier: 00351688060214
• UDI-Public: (01)00351688060214(17)270708(10)6029188
• 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): 02/28/2025

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: G1467J
• Device Lot Number: 6029188
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/12/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/05/2024
• Supplement Date Received by Manufacturer: 01/31/2025
• Initial Report FDA Received Date: 12/31/2024
• Supplement Report FDA Received Date: 02/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/26/2024
• 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