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

Model Number	21-7024-24
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the edge seen on the set's locking mechanism on a smiths medical device, which resulted in the inability to detach it from the machine.
Additional Manufacturer Narrative
Device evaluation: one device was returned for analysis in used and damaged condition.Visual inspection showed sample had been damaged and was in bad condition making an investigation impossible.Based on the investigation, the complaint allegation was not confirmed.

• Brand Name: CADD
• 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; minneapolis, MN 55442
• MDR Report Key: 13085548
• Report Number: 3012307300-2021-13290
• Device Sequence Number: 5433267
• Product Code: FPA
• UDI-Device Identifier: 10610586019852
• UDI-Public: 10610586019852
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K895046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/07/2022

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
• Device Model Number: 21-7024-24
• Device Catalogue Number: 21-7024-24
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 11/26/2021
• Supplement Date Received by Manufacturer: 05/10/2022
• Initial Report FDA Received Date: 12/25/2021
• Supplement Report FDA Received Date: 06/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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 Sex: Unknown