MAUDE Adverse Event Report: ST PAUL LEVEL 1; TEMPERTURE CATHETER

Model Number	FC400-16
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Codes	Pain (1994); Obstruction/Occlusion (2422)
Date of Event	12/01/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
Information received a smiths medical temperature probes|level 1 foley catheters was clogged.The affected lot numbers were provided.The patient endured discomfort as bacterial contamination occurred requiring treatment and longer stay in hospital.Ultrasound scan was performed for catheter reinsertion.Patient information on cover page.

• Brand Name: LEVEL 1
• Common Device Name: TEMPERTURE CATHETER
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• MDR Report Key: 11217776
• Report Number: 3012307300-2021-00634
• Device Sequence Number: 17045774
• 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: foreign
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date (Section B): 01/22/2021

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
• Device Catalogue 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: 01/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1