MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARDEX® LUBRICATH® TEMPERATURE SENSING FOLEY CATHETER

Model Number	A119418M
Medical Device Problem Code	Erratic or Intermittent Display (1182)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Information (3190)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete, a supplemental report will be filed.
Event or Problem Description
It was reported that the temperature sensing foley catheter was not functioning properly.Reportedly, the catheter was reporting low temperatures.Additional information was received via email on (b)(6) 2019 from (b)(6) who reported that "upon placement or very shortly thereafter, temperature readings would be very low or fall to very low level.Physical correlation was completed which verified incorrect values.".
Additional Manufacturer Narrative
The reported event was inconclusive due to an incorrect sample being returned.A microez microintroducer was returned instead of a foley temp sensing catheter.The lot number is unknown therefore the device history record could not be reviewed.The instructions for use were found adequate and state the following: ¿visually inspect the product for ay imperfections or surface deterioration prior to use." section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
Event or Problem Description
It was reported that the temperature sensing foley catheter was not functioning properly.Reportedly, the catheter was reporting low temperatures.Additional information was received via email on 8-jan-2019 from brian pratt who reported that "upon placement or very shortly thereafter, temperature readings would be very low or fall to very low level.Physical correlation was completed which verified incorrect values.".

• Brand Name: BARDEX® LUBRICATH® TEMPERATURE SENSING FOLEY CATHETER
• Common Device Name: TEMPERATURE SENSING FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8242658
• Report Number: 1018233-2019-00227
• Device Sequence Number: 11161301
• Product Code: EZC
• UDI-Device Identifier: 00801741073717
• UDI-Public: (01)00801741073717
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K910846
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,distributor,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/15/2019

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: A119418M
• Device Catalogue Number: 119418M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2019
• Initial Date Received by Manufacturer: 12/21/2018
• Supplement Date Received by Manufacturer: 05/08/2019
• Initial Report FDA Received Date: 01/11/2019
• Supplement Report FDA Received Date: 05/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1