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

Model Number 119314

Device Problems Partial Blockage (1065); Inaccurate Flow Rate (1249)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/01/2022

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The information provided by bd represents all 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 urine outflow could not be confirmed and the foley catheter was replaced.

Event Description

It was reported that urine outflow could not be confirmed and the foley catheter was replaced.Per follow up via ibc on 22aug2022, issue was against the catheter.

Manufacturer Narrative

The reported event was confirmed manufacturing related.1sample were confirmed to exhibit the reported failure.The device had not met specifications.The product was used for patient treatment.The product caused the reported failure.Visual evaluation of the returned sample noted one opened (without original packaging), used three-way temp sensing foley catheter attached to drainage bag.Visual inspection of the sample noted the catheter balloon was inflated with 10 ml methylene blue solution (3 drops 1% aq methylene blue per 100ml distilled water) and observed no issues with the inflation funnel.With the syringe attached the balloon was unable to deflated passively.Dissected the balloon and the notch was perforated.Also noted the catheter drainage lumen was flushed with methylene blue solution (3 drops 1% aq methylene blue per 100ml distilled water) and it was noted that the solution did not flow at all.The drainage lumen was cut to find extra silicone in the drainage lumen causing a complete blockage near the trifurcation.Although a specific cause cannot be determined, based on the risk document a potential root cause for this event could be ¿tooling misalignment".A review of the device history record did not show any problems or conditions that would have contributed to the reported issue.The investigation is concluded, and no additional action is required at this time.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." correction: d,f,g,h 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.H3 other text : the actual/suspected device was inspected.

• Brand Name: BARDEX® LUBRI-SIL® I.C. TEMPERATURE-SENSING ALL-SILICONE FOLEY CATHETER
• Type of Device: TEMPERATURE SENSING FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer (Section G): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 15307846
• MDR Text Key: 305538798
• Report Number: 1018233-2022-06705
• Device Sequence Number: 1
• Product Code: MJC
• UDI-Device Identifier: 00801741039843
• UDI-Public: (01)00801741039843
• 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: Other,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/23/2023

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: 119314
• Device Catalogue Number: 119314
• Device Lot Number: MYGN0124
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/18/2022
• Initial Date FDA Received: 08/28/2022
• Supplement Dates Manufacturer Received: 02/23/2023
• Supplement Dates FDA Received: 02/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/23/2022
• 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
• Patient Outcome(s): Other