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	01/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 syringe leaked in the cap when they are filled, and blood was leaking.There were unknown patient harm or adverse effects reported as a result of the event.
Additional Manufacturer Narrative
This complaint was incorrectly filed under this registration number, please reference mrn (b)(4) for details pertinent to this event.

• 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: 21463372
• Report Number: 1217052-2025-00048
• Device Sequence Number: 8840811
• Product Code: JKA
• UDI-Device Identifier: 20351688039191
• UDI-Public: (01)20351688039191(17)270806(10)6034878
• 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,Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/11/2025

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: 6034878
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/10/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/30/2025
• Supplement Date Received by Manufacturer: 01/30/2025
• Initial Report FDA Received Date: 02/25/2025
• Supplement Report FDA Received Date: 06/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/19/2024
• 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