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

Model Number 119112

Device Problem Misassembled (1398)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/28/2019

Event Type  malfunction  

Manufacturer Narrative

The reported event was confirmed as manufacturing related.Visual evaluation of the returned sample noted one opened (without original packaging), 3-way temperature sensing silicone foley catheter.Visual inspection of the sample noted a large piece of flash (measuring 0.1640 inches) on the shaft located 3.7835 inches from the tip of the catheter.The device history record was reviewed and found a possible manufacturing issue(s) that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: "to deflate catheter balloon: gently insert a syringe in the catheter valve.Never use more force than is required to make the syringe ¿stick¿ in the valve.If you notice slow or no deflation, re-seat the syringe gently.Allow the balloon to deflate slowly on its own.Do not aspirate or manually accelerate the deflation of the balloon.If permitted by hospital protocol, the valve arm may be severed.If this fails, contact adequately trained professional for assistance, as directed by hospital protocol.Should balloon rupture occur, care should be taken to assure that all balloon fragments have been removed from the patient.".

Event Description

It was reported that foreign material was found on the position about 10cm from the tip of the catheter.Per email received from the investigator on (b)(6) 2020, it was found during evaluation of the returned sample that the material was actually excess material/flash from the manufacturing process.

• Brand Name: BARDEX® ALL-SILICONE TEMPERATURE-SENSING FOLEY CATHETER
• Type of Device: TEMPERATURE SENSING CATHETER (SILICONE)
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• Manufacturer (Section G): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• Manufacturer Contact: yonic anderson ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 9699269
• MDR Text Key: 178753024
• Report Number: 1018233-2020-00962
• Device Sequence Number: 1
• Product Code: EZL
• UDI-Device Identifier: 00801741046018
• UDI-Public: (01)00801741046018
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K070582
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/12/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2023
• Device Model Number: 119112
• Device Catalogue Number: 119112
• Device Lot Number: NGDS1374
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/21/2020
• Initial Date FDA Received: 02/12/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/21/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1