MAUDE Adverse Event Report: ST PAUL LEVEL 1; UROLOGICAL CATHETER AND ACCESSORIES

Model Number	FC400-16
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Information (3190)
Date of Event	12/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Customer facility phone: (b)(6).
Event or Problem Description
Information was received indicating that a smiths medical catheter was clogged.This issue happened at least 5 times during the last three weeks.There were no reported adverse events.

• Brand Name: LEVEL 1
• Common Device Name: UROLOGICAL CATHETER AND ACCESSORIES
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• MDR Report Key: 11194522
• Report Number: 3012307300-2021-00565
• Device Sequence Number: 3927758
• Product Code: KOD
• UDI-Device Identifier: 10695085000501
• UDI-Public: 10695085000501
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K873448
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date (Section B): 01/19/2021

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 Model Number: FC400-16
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/29/2020
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/23/2020
• Initial Report FDA Received Date: 01/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1