MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX ABG PROVENT PLUS, 3ML LL SYRINGE; TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION

Catalog Number	4558PECN
Medical Device Problem Code	Separation Problem (4043)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/13/2025
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 in front of the arterial kit was separated and could not be used.The blood collection kit was eventually replaced, and the puncture was redone.There were no patient harm or adverse events reported as a result of the event.
Additional Manufacturer Narrative
No product samples, pictures, or videos were received for investigation.The complaint of syringe separation could not be confirmed by investigation.Without the return of the used sample a comprehensive failure investigation cannot be performed, and a cause cannot be determined.A lot of history review could not be conducted because no lot number was provided by the customer.

• Brand Name: PORTEX ABG PROVENT PLUS, 3ML LL SYRINGE
• 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 ln n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 21381337
• Report Number: 1217052-2025-00043
• Device Sequence Number: 8461597
• Product Code: JKA
• UDI-Device Identifier: 20351688039108
• UDI-Public: (01)20351688039108
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/02/2025

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: 4558PECN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2025
• Supplement Date Received by Manufacturer: 11/13/2025
• Initial Report FDA Received Date: 02/13/2025
• Supplement Report FDA Received Date: 12/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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