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

Catalog Number	G1460J
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when staff tried to let the air out with the filter pro, the filter pro flew out.The event occurred during patient in use/dose.There is no adverse event.
Additional Manufacturer Narrative
B3: day of event unknown.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
Additional Manufacturer Narrative
One device was returned for analysis of complaint that when staff tried to let the air out with the filter pro, the filter pro flew out.Pictures were also provided.Visual evaluation showed that liquid had exceeded the 0.06" acceptance criteria and escaped through the top collar on one of the filter-pros, confirming complaint.The area of leakage was inspected, however due to the sample being used, it could not be stated with confidence whether the area was damaged, had a short fill or was not properly sealed.While the allegation was confirmed, the exact problem source for the compromised filter-pro could not be identified with any confidence.No further action will be conducted at this time.Complaint information will continue to be monitored for any new information or adverse trends and further actions taken accordingly.Device history review (dhr) found no discrepancies or anomalies relevant to the complaint.

• Brand Name: PORTEX ABS PRO-VENT 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 lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 22160037
• Report Number: 1217052-2025-00083
• Device Sequence Number: 12633573
• Product Code: JKA
• UDI-Device Identifier: 00351688060146
• UDI-Public: (01)00351688060146(17)270625(10)6029235
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/22/2025

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: G1460J
• Device Lot Number: 6029235
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/06/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/15/2025
• Supplement Date Received by Manufacturer: 07/09/2025
• Initial Report FDA Received Date: 06/06/2025
• Supplement Report FDA Received Date: 07/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/23/2024
• 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