MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARDEX® I.C. COMPLETE CARE® TEMP-SENSING FOLEY CATHETER WITH URINE METER; TEMP SENSING FOLEY TRAY

Model Number	319416AM
Medical Device Problem Code	Restricted Flow rate (1248)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); 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 device was not received.
Event or Problem Description
It was reported that the drain bag from the temperature sensing foley tray developed a vapor lock, preventing urine from draining into the drain bag.
Additional Manufacturer Narrative
The device was not returned for evaluation.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: ¿single use only.Do not re-sterilize.For urological use only.Warning: on catheter, do not use ointments or lubricants having a petrolatum base.They will damage the catheter and may cause balloon to burst.Warning: after use, this product may be a potential biohazard.Handle and dispose of in accordance with accepted medical practices and applicable local, state and federal laws and regulations.Visually inspect the product for any imperfections or surface deterioration prior to use.If package is opened or if any imperfection or surface deterioration is observed, do not use.Please consult product label and insert for any indications, contraindications, hazards, warnings, cautions and directions for use.".
Event or Problem Description
It was reported that the drain bag from the temperature sensing foley tray developed a vapor lock, preventing urine from draining into the drain bag.

• Brand Name: BARDEX® I.C. COMPLETE CARE® TEMP-SENSING FOLEY CATHETER WITH URINE METER
• Common Device Name: TEMP SENSING FOLEY TRAY
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8235841
• Report Number: 1018233-2019-00216
• Device Sequence Number: 1558295
• Product Code: MJC
• UDI-Device Identifier: 00801741024450
• UDI-Public: (01)00801741024450
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/12/2019

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 Expiration Date: 01/31/2021
• Device Model Number: 319416AM
• Device Catalogue Number: 319416AM
• Device Lot Number: NGCV1197
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/21/2018
• Supplement Date Received by Manufacturer: 02/19/2019
• Initial Report FDA Received Date: 01/10/2019
• Supplement Report FDA Received Date: 03/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1