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 (b)(6) 2025.There was patient involvement.There has been no report of patient harm.
Additional Manufacturer Narrative
E1 phone number: (b)(6).H3 - other: device has not been returned to date.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.
Additional Manufacturer Narrative
Five samples were originally received were lost in transit.However, new sister samples under a different complaint confirmed failure in two new sets.It was reported that the filter cap for the blood gas syringes leaks blood after sampling.The dhr (device history record) review found no discrepancies or anomalies relevant to the complaint.The complaint of leaking filter caps can be confirmed based on new sister samples received for the same lot number.While the allegation was confirmed, the exact problem source for the compromised filter-pros could not be identified with any confidence.If samples originally received for this complaint are located, investigation will be reopened and reevaluated.

• 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 north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 21359061
• Report Number: 1217052-2025-00037
• Device Sequence Number: 15557599
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/24/2026

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: Other
• Device Catalogue Number: 4043E
• Device Lot Number: 6034882
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/04/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/20/2025
• Supplement Date Received by Manufacturer: 03/04/2026
• Initial Report FDA Received Date: 02/11/2025
• Supplement Report FDA Received Date: 03/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/22/2024
• 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): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown