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

Model Number 119112

Device Problems Deflation Problem (1149); Fluid/Blood Leak (1250); Gas/Air Leak (2946); Device Fell (4014)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 10/03/2019

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 fell out of the patient with a deflated balloon due to a water leakage, 2 days after the placement.

Manufacturer Narrative

The reported event was unconfirmed, since the reported failure could not be reproduced.The product was used for diagnostic and treatment purposes.Visual inspection noted one temperature sensing catheter without original packaging attached to sample port, cut inlet tube and cut thermistor wire was received.Visual evaluation of the sample noted no obvious defects.The catheter balloon was inflated with 5.5 ml methylene blue solution and distilled water and balloon concentricity was observed to be 50:50.The balloon rested for 30 minutes without leaks and passively deflated without issue or cuffing, returning 5.5ml of solution.The catheter balloon inflated and deflated normally with the use of a syringe, which made it within specifications.The drainage lumen was flushed with methylene blue solution (3 drops 1% aq methylene blue per 100ml of distilled water).Active length of the catheter balloon was measured (0.6985") and found to be within specification (0.50" - 0.80").The catheter was measured to be 12 fr.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: ¿to deflate and remove the balloon, attach a needleless syringe to let sterile water in the balloon come out spontaneously through balloon deflation without aspiration.After balloon deflation, withdraw the catheter slowly while confirming that no abnormal resistance is encountered." h11:section a through f - the information provided by bd 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 bd.

Event Description

It was reported that the catheter fell out of the patient with a deflated balloon due to water leakage, 2 days after the placement.

• Brand Name: BARDEX® ALL-SILICONE TEMPERATURE-SENSING FOLEY CATHETER
• Type of Device: FOLEY CATHETER (SILICONE)
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9235362
• MDR Text Key: 177176714
• Report Number: 1018233-2019-06788
• Device Sequence Number: 1
• Product Code: EZL
• UDI-Device Identifier: 00801741046018
• UDI-Public: (01)00801741046018
• 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: 11/06/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2024
• Device Model Number: 119112
• Device Catalogue Number: 119112
• Device Lot Number: NGDP0456
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2019
• Initial Date Manufacturer Received: 10/04/2019
• Initial Date FDA Received: 10/24/2019
• Supplement Dates Manufacturer Received: 10/30/2019
• Supplement Dates FDA Received: 11/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1