MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. ABG PROVENT PLUS; SYRINGE, ANTISTICK

Catalog Number	4558PECN
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/22/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that blood gas analysis was prepared for the patient.When the arterial blood gas needle was examined it was not found that the needle was not tightly connected to the needle.The needle fell off and the arterial blood collection kit was immediately replaced with a new one.There was patient involvement and no patient harm/adverse event reported.
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.
Additional Manufacturer Narrative
H6: evaluation codes updated.No product sample has been provided, and the investigation could not confirm whether a quality related issue has resulted in the customer reported problem.A device history record (dhr) review was performed for lot number 4396456 and no discrepancies or non-conformances during the manufacturing of the reported lot number.

• Brand Name: ABG PROVENT PLUS
• Common Device Name: SYRINGE, ANTISTICK
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 10 bowman dr; keene NH 03431
• Manufacturer Contact: reed covert ; 6000 nathan lane n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 20240831
• Report Number: 1217052-2024-00107
• Device Sequence Number: 8667552
• Product Code: JKA
• UDI-Device Identifier: 20351688039108
• UDI-Public: (01)20351688039108(17)260501(10)4396456
• 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: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/07/2025

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 Expiration Date: 05/01/2026
• Device Catalogue Number: 4558PECN
• Device Lot Number: 4396456
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2024
• Supplement Date Received by Manufacturer: 12/12/2024
• Initial Report FDA Received Date: 09/17/2024
• Supplement Report FDA Received Date: 01/07/2025
• 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