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

Model Number 119314

Device Problems Decrease in Pressure (1490); Device Dislodged or Dislocated (2923); Improper Flow or Infusion (2954)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/28/2020

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 fell out and there was no water 30 min after the placement.Per additional information received from ibc via mail on 04sep2020, there was no visible damage.

Manufacturer Narrative

The reported event was unconfirmed since the problem could not be reproduced.Visual inspection noted one temperature sensing catheter attached to a cut portion of inlet tubing was received without the original packaging.No obvious defects were noted.The catheter balloon was inflated with 10 ml methylene blue solution (3 drops 1% aq methylene blue per 100ml distilled water) and balloon concentricity was observed to be 60:40.This meets specification as concentricity should not exceed 70:30.The balloon rested for 30 minutes without leaks and passively deflated without issue or cuffing, returning 10ml of solution.Drainage lumen was flushed, and no leaks were observed.This meets specifications as balloon fill being complete with no holes or tears.This meets specifications as no holes or damage being found on the shaft during testing.Active length of the catheter balloon was measured (0.8835") and found to be within specification (0.60" - 0.90").Although the reported event was unconfirmed, the most likely potential root cause for the reported failure could be inserts with edges (the operator hits the shaft against the bottom insert when removing the piece of the mold).The device history record review was not required as the reported event was unconfirmed.The instructions for use were found adequate and state the following: "warning: on catheter, do not use ointments or lubricants having petrolatum base.They will damage silicone and may cause the balloon to burst.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: federal (u.S.A.) law restricts this device to sale by or on the order of a physician.Caution: do not aspirate urine through drainage funnel wall.Storage: store catheters at room temperature away from direct exposure to light, preferably in the original box.Sterile unless package is opened or damaged.Single patient use only.Do not reuse.Do not resterilize.For urological use only.Valve type: use luer slip syringe.Do not use needle.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.Catheters should be replaced in accordance with the cdc guideline ¿guideline for prevention of catheter-associated urinary tract infection¿.At the onset or first signs of a urinary tract infection, catheter encrustation, or any other catheter-related adverse effect, the catheter should be replaced.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 luer slip tip 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.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.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.".

Event Description

It was reported that the catheter fell out and there was no water 30 min after the placement.Per additional information received from ibc via mail on 04sep2020, there was no visible damage.

• Brand Name: BARDEX LUBRI-SIL I.C. TEMPERATURE-SENSING ALL-SILICONE 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: 10560659
• MDR Text Key: 208561887
• Report Number: 1018233-2020-06094
• Device Sequence Number: 1
• Product Code: MJC
• UDI-Device Identifier: 00801741039843
• UDI-Public: (01)00801741039843
• 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: 01/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 119314
• Device Catalogue Number: 119314
• Device Lot Number: NGDX1817
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2020
• Date Manufacturer Received: 12/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1