MAUDE Adverse Event Report: ST PAUL DELTEC; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	21-2965-24
Medical Device Problem Code	Improper Flow or Infusion (2954)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/11/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a nurse noticed the presence of air in a smiths medical syringe once the needle was already installed.The issue occurred twice.They used another needle from the same lot number and there were no issue.No adverse patient effects were reported.

• Brand Name: DELTEC
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• MDR Report Key: 11364528
• Report Number: 3012307300-2021-01458
• Device Sequence Number: 4038059
• Product Code: FPA
• UDI-Device Identifier: 10610586027734
• UDI-Public: 10610586027734
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K021999
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/23/2021

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: 08/31/2025
• Device Model Number: 21-2965-24
• Device Catalogue Number: 21-2965-24
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/19/2021
• Initial Report FDA Received Date: 02/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1