MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. LEVEL 1® TEMPERATURE-SENSING FOLEY CATHETER; CATHETER, UROLOGICAL

Catalog Number	FC400-16
Medical Device Problem Code	Invalid Sensing (2293)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/19/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Report source: country of origin: (b)(6).
Event or Problem Description
It was reported that during use of this level 1® temperature-sensing foley catheter, the temperature display was inaccurate, causing delay in treatment for infection and hypothermia.The catheter had been in use approximately 15 days prior to this issue.The reading measured 36.1° whereas the central catheter measured 38.6°.Medical treatment was prescribed, and the infection and hypothermia resolved.No permanent injury was reported.
Additional Manufacturer Narrative
One level 1® temperature-sensing foley catheter was received for investigation.The device appeared to have been used as there was a slight amount of urine contents that remained and the cuff material was stretched and would not conform back to the shape of the shaft.The device was first inspected for any molding defects, short fills, voids, and/or flow lines, but nothing was observed.There was no way to test or replicate the reported defect.

• Brand Name: LEVEL 1® TEMPERATURE-SENSING FOLEY CATHETER
• Common Device Name: CATHETER, UROLOGICAL
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 6804980
• Report Number: 3012307300-2017-01904
• Device Sequence Number: 19205009
• 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,health professional,u
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 03/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Pharmacist
• Device Expiration Date: 02/13/2020
• Device Catalogue Number: FC400-16
• Device Lot Number: 957002
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 02/14/2018
• Initial Report FDA Received Date: 08/18/2017
• Supplement Report FDA Received Date: 03/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other