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

Model Number	919116AM
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
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.The information provided by bard 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 bard.
Event or Problem Description
It was reported that there are black spots on the white wire of the temp sensing foley.
Additional Manufacturer Narrative
The reported issue was confirmed.The device was returned for evaluation.Visual inspection found dark spots/foreign material on the white wire.Unable to identify material.Unable to determine if the material came into contact with the wire prior to or post shipping from moncks corner facility.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use states the following: ¿visually inspect the product for any imperfections or surface deterioration prior to use.If package is opened or damaged or if any imperfection or surface deterioration is observed, do not use." (b)(4).
Event or Problem Description
It was reported that there were black spots on the white wire of the temp sensing foley.
Additional Manufacturer Narrative
The reported issue was confirmed.The device was returned for evaluation.Visual inspection found dark spots/foreign material on the white wire.Unable to identify material.Unable to determine if the material came into contact with the wire prior to or post shipping from moncks corner facility.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use states the following: ¿visually inspect the product for any imperfections or surface deterioration prior to use.If package is opened or damaged or if any imperfection or surface deterioration is observed, do not use." (b)(4).
Event or Problem Description
It was reported that there were black spots on the white wire of the temp sensing foley.

• Brand Name: BARDEX® I.C. TEMPERATURE SENSING FOLEY CATHETER
• Common Device Name: CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 6727225
• Report Number: 1018233-2017-03838
• Device Sequence Number: 13764000
• Product Code: MJC
• UDI-Device Identifier: 00801741040047
• UDI-Public: (01)00801741040047
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K040658
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/22/2018

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 Expiration Date: 06/30/2019
• Device Model Number: 919116AM
• Device Catalogue Number: 129416M
• Device Lot Number: CM6043
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2017
• Initial Date Received by Manufacturer: 06/27/2017
• Supplement Date Received by Manufacturer: 09/06/2017; 02/16/2018
• Initial Report FDA Received Date: 07/19/2017
• Supplement Report FDA Received Date: 09/22/2017; 02/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1