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	01/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that 3 syringes were tested and 2 of them leaked in the cap, whereas one of them leaked blood on the sides.There was patient involvement, and no patient harm/adverse event reported.
Additional Manufacturer Narrative
This file was originally incorrectly filed under registration number mrn 1217052-2025-00048-00.The date of that submission was 25-feb-2025.B3.Date of event: it was reported that the event occurred between 25-27-jan-2025.Investigation summary: received for investigation five used not fully decontaminated 3ml syringes with filter-pro devices.The customer also provided a picture of the reported issue.Review of the photo showed that the blood had exceeded the maximum allowance of 0.06" and traveled to the collar of the filter-pro on three components.In one instance a droplet had escaped through the top of the housing.To further evaluate this claim, one of the returned samples was functionally tested by simulated use.A test syringe was partially filled with dye-solution.While holding the luer of the syringe uppermost the plunger was pulled back to allow an air pocket.The filter-pro (cap) was seated onto the syringe luer according to the ifu (instructions for use), using a push and twist motion to fully seat the components together.The syringe was gently tapped to move all trapped air towards the luer of the syringe.The plunger was slowly advanced upward (toward the zero mark) until the trapped air was displaced through the filter-pro device and the fluid contacted the filter material, sealing off the syringe contents.Results: the tested sample did not pass the acceptance criteria.The fluid was 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) visual inspection for damages, that affect function and dhr (device history record) 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.This issue has been discussed with a quality engineer and the manufacture has been notified.Complaint information will continue to be monitored for any new information or adverse trends and further actions will be taken accordingly.

• 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: 22186959
• Report Number: 3012307300-2025-06889
• Device Sequence Number: 20933153
• 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,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/30/2025
• Initial Report FDA Received Date: 06/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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