MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX; TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION

Model Number	4611P-1
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/05/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Pro-vent arterial blood sampling kit.The unopened package has a clear plastic front and it is visible that the package does not contain the syringe and needle to retrieve blood.While only one of these was retained, the respiratory therapist reported that there were four or five other abg kits without the syringe and needle as well.

• Brand Name: PORTEX
• Common Device Name: TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 10 bowman drive; keene NH 03431
• MDR Report Key: 7605106
• Report Number: 7605106
• Device Sequence Number: 1759571
• Product Code: JKA
• UDI-Device Identifier: 20351688042306
• UDI-Public: (01)20351688042306
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/05/2018
• Report Date (Section F): 06/05/2018

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: No Information
• Device Expiration Date: 11/30/2019
• Device Model Number: 4611P-1
• Device Lot Number: 3604103
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 06/05/2018
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 06/05/2018