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

Catalog Number	4558PG
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3: date of event is unknown; no information has been provided to date.H3: device 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 thread of the syringe is deformed: it is oval instead of round, which makes it difficult to remove the needle post-collection.The filter is not waterproof, it is leaking, and blood is flowing.There was patient involvement but no patient harm.
Additional Manufacturer Narrative
D9: 25-apr-2025.H3: two 3ml syringes with used filter-pros were received for evaluation of lot # 6029282, along with pictures.Review of the photo's pre-decontamination showed that the blood had exceeded the maximum allowance of 0.06" and traveled to the collar of the filter-pro.Visual inspection noted that the luer was slightly misshapen on one syringe.Functional testing was performed, and no issues were noted.Based on the results of this investigation, the complaint was confirmed of a misshapen luer and defective pros.Maintenance log review found no entries relevant to the reported problem on the date of manufacture.While the allegation was confirmed, the exact problem source for the compromised filter-pros could not be identified with any confidence.Complaint information will continue to be monitored for any new information or adverse trends and further actions will be taken accordingly.A device history review 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: 21734055
• Report Number: 3012307300-2025-03534
• Device Sequence Number: 4007549
• Product Code: JKA
• UDI-Device Identifier: 20351688081169
• UDI-Public: (01)20351688081169(17)270715(10)6029282
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K952516
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• 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): 07/16/2025

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: 4558PG
• Device Lot Number: 6029282
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2025
• Supplement Date Received by Manufacturer: 06/23/2025
• Initial Report FDA Received Date: 03/31/2025
• Supplement Report FDA Received Date: 07/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/13/2024
• 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