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

Model Number 119108

Device Problems Device Damaged Prior to Use (2284); Material Twisted/Bent (2981)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.

Event Description

It was reported that, prior to use, the temperature probe sensor was observed to be coiled and the tip of the probe was not near the tip of the catheter.

Manufacturer Narrative

The reported event was confirmed but a root cause could not be determined.The investigator received a meter drain bag with a temperature sensing catheter.The temperature sensing wire was observed to be kinked and not in the tip of the catheter, as the standard states "the wire should not be kinked, knotted or broken once is inserted in the lumen." 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: ¿sterile unless package is open or damaged, except for the hand sterilizer and cleansing wipe which are not terminally sterilized.".

Event Description

It was reported that, prior to use, the temperature probe sensor was observed to be coiled and the tip of the probe was not near the tip of the catheter.

• Brand Name: BARDEX® ALL-SILICONE TEMPERATURE-SENSING PEDIATRIC FOLEY CATHETER
• Type of Device: TEMPERATURE SENSING FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8344480
• MDR Text Key: 136617963
• Report Number: 1018233-2019-00843
• Device Sequence Number: 1
• Product Code: EZL
• UDI-Device Identifier: 00801741045998
• UDI-Public: (01)00801741045998
• Combination Product (y/n): N
• PMA/PMN Number: K070582
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 05/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2021
• Device Model Number: 119108
• Device Catalogue Number: 119108
• Device Lot Number: NGCS3907
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2019
• Date Manufacturer Received: 05/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1