MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX ABS PRO-VENT ARTERIAL BLOOD SAMPLING; TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION

Catalog Number	4590PG
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/07/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: 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 when drawing blood, it did not create a vacuum, it sucked in air instead of blood, which caused the blood to foam outside the syringe.The event happened during the immediate use of the product.There was patient involvement, and there was no patient harm reported.No medical intervention was required.
Additional Manufacturer Narrative
No product was returned; however, a picture was attached depicting the customer's reported issue.Review of the photo shows that the blood had leaked past the rubber stopper.Although the complaint was confirmed, without an actual sample, no further product evaluation could be performed for this specific complaint.The root cause of the issue couldn't be identified.All materials used in the manufacturing process, as well as all finished goods products are released to market based on approved quality specifications.Incoming and in-process documentation review revealed that all required testing was performed, and the product met established acceptance requirements.Without the return of the samples a comprehensive failure investigation cannot be performed, and a probable cause cannot be determined.If the product is returned, the manufacturer will reopen this complaint for further investigation.

• Brand Name: PORTEX ABS PRO-VENT ARTERIAL BLOOD SAMPLING
• 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: 21942738
• Report Number: 3012307300-2025-05113
• Device Sequence Number: 20966086
• Product Code: JKA
• UDI-Device Identifier: 20351688081183
• UDI-Public: (01)20351688081183(17)271118(10)6076962
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 07/21/2025

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: 4590PG
• Device Lot Number: 6076962
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/07/2025
• Supplement Date Received by Manufacturer: 07/08/2025
• Initial Report FDA Received Date: 05/01/2025
• Supplement Report FDA Received Date: 07/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/09/2024
• 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