MAUDE Adverse Event Report: ST PAUL CADD ADMINISTRATION SETS WITH AIR-ELIMINATING FIL; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	21-7336-24
Medical Device Problem Code	Device Alarm System (1012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/13/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A product sample was received at the investigation site for evaluation.Visual and functional testing were performed.Functional testing of the accuracy of the device was conducted successfully.All testing and product evaluation shows no fault found on the suspect device.The root cause of the reported issue therefore can not be confirmed given that the device passed all testing and inspections.No further actions can be conducted since the complaint was not confirmed.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.This remediation mdr was generated under protocol b10009406, as a result of warning letter cms# 617147.
Event or Problem Description
It was reported that the suspect device was in use on a patient at the time of the incident, however, there was no patient harm.The suspect device was removed with the tip in tack, the alarm sounded which indicated that the bag was empty, in which, the customer decided to replace the suspect device and the issue was resolved: no patient injury was reported.

• Brand Name: CADD ADMINISTRATION SETS WITH AIR-ELIMINATING FIL
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; north carolina division; minneapolis, MN 55442
• MDR Report Key: 15294919
• Report Number: 3012307300-2022-16235
• Device Sequence Number: 20409282
• Product Code: FPA
• UDI-Device Identifier: 10610586027291
• UDI-Public: 10610586027291
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K040636
• 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): 08/25/2022

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: 03/11/2025
• Device Model Number: 21-7336-24
• Device Catalogue Number: 21-7336-24
• Device Lot Number: 3955214
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2021
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/24/2022
• Initial Report FDA Received Date: 08/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/30/2020
• 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
• Patient Sequence Number: 1
• Patient Age: 38 YR
• Patient Sex: Female
• Patient Weight: 55 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White