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

Model Number	21-3468-24
Medical Device Problem Code	Suction Problem (2170)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/20/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation in progress.
Event or Problem Description
It was reported during aspiration, the device drew back air with spurts of blood.No patient injury or further complications were reported in relation to this event.
Additional Manufacturer Narrative
Other, other text: g3: the complaint was reported to the fda under uf/importer report number 2700040000-2021-8002 h2: additional information: see a2, a3, b3, g3, h6 (patient code).
Additional Manufacturer Narrative
H6: event problem and evaluation codes: updated after device evaluation.Device evaluation: the device was returned for investigation.A visual inspection and functional test were performed.Units received: one unit was received for evaluation.Visual inspection: the returned unit was received decontaminated without its original packaging.Functional testing: one unit was tested by introducing water with a syringe in order to verify for air in line.Results: no air was detected.After sample evaluation the complaint was not confirmed.The cause of the reported problem could not be determined.No corrective actions were implemented since complaint was not confirmed.

• Brand Name: DELTEC
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): NULL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer Contact: david halverson ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 11440345
• Report Number: 3012307300-2021-01810
• Device Sequence Number: 14831015
• Product Code: FPA
• UDI-Device Identifier: 10610586033070
• UDI-Public: 10610586033070
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K072657
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/09/2022

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: 09/08/2025
• Device Model Number: 21-3468-24
• Device Catalogue Number: 21-3468-24
• Device Lot Number: 4027427
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2021
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/08/2021
• Supplement Date Received by Manufacturer: 03/15/2021; 05/01/2021
• Initial Report FDA Received Date: 03/08/2021
• Supplement Report FDA Received Date: 04/13/2021; 03/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/21/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Patient Sex: Female