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

Model Number 119108

Device Problems Fluid/Blood Leak (1250); Decrease in Pressure (1490)

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

Event Date 07/09/2020

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 the catheter was difficult to inflate due to water leakage during pretest.

Manufacturer Narrative

The reported event was confirmed.Visual inspection noted one temperature sensing catheter was received.Visual evaluation noted no obvious defects.Attempted to inflate the catheter's balloon with 3.5 ml methylene blue solution (3 drops 1% aq methylene blue per 100ml distilled water) and the solution immediately leaked out of the eyelets.The balloon was dissected to find that the inflation notch perforated both lumens.This fails to meet specifications per ip7602317 rev 19 stating "eye punching must not penetrate the inflation, irrigation lumen and/or thermistor." although the reported event was confirmed, a root cause could not be determined.A potential root cause for this failure could be punch depth too large.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.A labeling review was not performed because labeling could not have prevented the reported failure.

Event Description

It was reported that the catheter was difficult to inflate due to water leakage during pretest.

• Brand Name: BARDEX ALL-SILICONE TEMPERATURE-SENSING PEDIATRIC FOLEY CATHETER
• Type of Device: TEMPERATURE SENSING CATHETER (SILICONE)
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 10380106
• MDR Text Key: 202997980
• Report Number: 1018233-2020-05048
• 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: distributor,other
• Type of Report: Initial,Followup
• Report Date: 11/15/2020

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 Model Number: 119108
• Device Catalogue Number: 119108
• Device Lot Number: NGDX0337
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2020
• Initial Date Manufacturer Received: 07/16/2020
• Initial Date FDA Received: 08/07/2020
• Supplement Dates Manufacturer Received: 10/23/2020
• Supplement Dates FDA Received: 11/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1