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

Model Number 119108

Device Problems Deflation Problem (1149); Inaccurate Flow Rate (1249)

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

Event Date 12/14/2018

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The device was not returned.

Event Description

It was reported that it was difficult to deflate the catheter balloon.Additional information was received from (b)(6) via email on (b)(6) 2018, that the catheter was finally removed and no medical treatment was required.

Manufacturer Narrative

The reported event was confirmed as manufacturing related due to the excess material causing blockage.Visual evaluation of the returned sample noted one opened (without original packaging), used silicone temperature sensing foley catheter.The drainage lumen was flushed with methylene blue solution (3 drops 1% aq methylene blue per 100ml of distilled water) and was unable to flow pass the funnel end of the trifurcation.A surrogate bladder was filled with methylene blue solution (3 drops 1% aq methylene blue per 100ml of distilled water).The catheter was placed inside and inflated with methylene blue solution.The bladder was then inverted to simulate the environment of the bladder and drainage from the drainage eyes into the lumens, but the solution could not flow pass the trifurcation.When the funnel was dissected, it was noted that the funnel was filled with silicone near the trifurcation.Material in the drainage lumen is out of specification.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: ¿warning: do not use ointments or lubricants having a petrolatum base.They will damage silicone and may cause balloon to burst.Caution: do not aspirate urine through the drainage funnel wall.Storage: store catheters at room temperature away from direct exposure to light, preferably in the original box.Single use only.Do not reuse.Do not resterilize.For urological use only.Valve type: use luer slip syringe.Do not use needle.Recommended inflation capacities 8 fr.And 10 fr.(3cc balloon): use 3.5cc sterile water 12 fr.(5cc balloon): use 5.5cc sterile water 14 fr.And larger (5cc balloon): use 10cc sterile water do not exceed recommended capacities.Warning: after use, this product may be a potential biohazard.Handle and dispose of in accordance with applicable local, state, and federal laws and regulations.Caution: aggressive traction, particularly in the presence of suturing, is not recommended for 100% silicone balloon foley catheters.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.Visually inspect the product for any imperfections or surface deterioration prior to use.Note: compatible only with the bard criticore monitor, bard urotrack 224 monitor, and other 400-series temperature monitors.Interchangeability + 0.2oc at 37oc.Warning: this product should never be connected to the temperature monitor or connected to a cable during an mri procedure.Failure to follow this guideline may result in serious injury to the patient.It is important to closely follow these specific conditions that have been determined to permit the examination to be conducted safely.Any deviation may result in a serious injury to the patient.Caution: as with all temperature probes, in the presence of rf energy sources, local heating, temperature errors, and probe damage may occur.Do not stretch catheter.This will cause repositioning of probe.Do not use stylet.This will cause stretching of catheter.".

Event Description

It was reported that it was difficult to deflate the catheter balloon.Additional information was received from the ibc via email on 19dec2018, that the catheter was finally removed and no medical treatment was required.Per additional information from the sales rep received by the medicon team on 17jan2019, the failure was not difficult to deflate.The actual failure was difficulty in draining urine from the catheter.Per additional information from the ibc via email 24jan2019; there was no medical intervention needed for the urine retention or other conditions.

• Brand Name: BARDEX® ALL-SILICONE TEMPERATURE-SENSING PEDIATRIC FOLEY CATHETER
• Type of Device: TEMPRETURE SENSING CATHETER (SILICONE)
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8233179
• MDR Text Key: 132632862
• Report Number: 1018233-2019-00208
• 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: 04/17/2019

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: 08/31/2022
• Device Model Number: 119108
• Device Catalogue Number: 119108
• Device Lot Number: NGBV2981
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2019
• Initial Date Manufacturer Received: 12/17/2018
• Initial Date FDA Received: 01/10/2019
• Supplement Dates Manufacturer Received: 03/26/2019
• Supplement Dates FDA Received: 04/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1