MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX SYRINGE LUER FILTER PRO; TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION

Catalog Number	4043E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the filter cap of the blood gas syringes leaks blood after sampling.No patients were harmed.
Additional Manufacturer Narrative
This file was originally incorrectly filed under registration number mrn 1217052-2025-00026.The date of that submission was 02- feb-2025.Received one device, two of the tested samples did not pass the acceptance criteria.The dyed liquid exceeded the maximum allowance of 0.06" and traveled to the collar of the filter-pro escaping through the top of the housing.Based on the results of this investigation the complaint was confirmed.In-process, filter-pro devices are automatically assembled and glued from supplied components.Maintenance log review found no entries relevant to the reported problem on the date of manufacture.The lot acceptance is based on c=0 (critical) inspection for damages, that affect function and dhr information indicates the lot met the established acceptance requirements.While the allegation was confirmed, the exact problem source for the compromised filter-pros could not be identified with any confidence.Device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.

• Brand Name: PORTEX SYRINGE LUER FILTER PRO
• 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: 22198361
• Report Number: 3012307300-2025-06985
• Device Sequence Number: 12946176
• Product Code: JKA
• UDI-Device Identifier: 20351688039191
• UDI-Public: (01)20351688039191(17)270731(10)6034882
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• 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,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 06/12/2025

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: 4043E
• Device Lot Number: 6034882
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/08/2025
• Initial Report FDA Received Date: 06/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/27/2024
• 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