MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX ABS LINEDRAW DRY HEPARIN; TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION

Catalog Number	4043E
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/20/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the filter cap for the blood gas syringes leaks blood after sampling.The event date is 20-jan-2025.There was patient involvement.There has been no report of patient harm.
Additional Manufacturer Narrative
Correction: this file was originally incorrectly filed under registration number mrn 1217052-2025-00035.The date of that submission was 11-feb-2025.Investigation results: received four devices, the customer also provided pictures of the reported issue.Evaluation of the provided photos shows that a bloodlike substance exceeded the maximum allowance of 0.06" and traveled to the collar of the filter-pro.The problem could not be replicated with the returned samples.The samples passed the acceptance criteria.Functional test shows that the dyed liquid did not exceed the maximum allowance of 0.06" liquid through the filter-pro.The problem could not be replicated with the returned samples.Based on the results of this investigation the complaint could not be confirmed.Dhr's review found no discrepancies or anomalies relevant to the complaint.In process, the product was inspected for filter-pro glue to be visible around entire outside edge of filter, and damage to component that compromises function.No anomalies were noted.

• Brand Name: PORTEX ABS LINEDRAW DRY HEPARIN
• 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 n.; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 22204037
• Report Number: 3012307300-2025-07031
• Device Sequence Number: 7723041
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/13/2025

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: 02/17/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/20/2025
• Initial Report FDA Received Date: 06/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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