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

Model Number 129416M

Device Problems Leak/Splash (1354); Dent in Material (2526); No Flow (2991)

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

Event Date 03/15/2020

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 foley catheter was leaking and the nurse withdrew the water and there was only 8 cc of fluid in the balloon.She reinflated the balloon with 10 cc and the foley would not drain.She scanned the patient¿s bladder and found 200cc of residual urine.

Manufacturer Narrative

The reported event is confirmed as manufacturing-related.The root cause of this failure is operator error in missing the asymmetrical balloon defect during water test of the assembly procedure, resulting in stress on the patient's kidney and causing a ripple effect, resulting in urine leaking around the catheter.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: "bardex® i.C.¿ anti-infective foley catheter with bard® hydrogel and bacti-guard®* silver alloy coating infection control temperature-sensing 400-series foley catheter caution: this product contains natural rubber latex which may cause allergic reactions.Caution: do not aspirate urine through drainage funnel wall.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.Warning: on catheter, do not use ointments or lubricants having petrolatum base.They will damage latex and may cause the balloon to burst.Valve type: use luer slip syringe.Do not use needle.Sterile unless package is opened or damaged.Single patient use only.Do not reuse.Do not resterilize.For urological use only.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.Allow the pressure within the balloon to force the plunger back and fill the syringe with water.If you notice slow or no deflation, re-seat the syringe gently.Use only gentle aspiration to encourage deflation if needed.Vigorous aspiration may collapse the inflation lumen, preventing balloon deflation.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.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.As with all temperature probes, in the presence of rf energy sources, local heating, temperature errors, and probe damage may occur.In medical use, unplug the temperature sensing catheter at the temperature monitor before activating electrosurgical or other types of direct coupled rf energy sources.Storage: store catheters at room temperature away from direct exposure to light, preferably in the original box.Note: compatible with appropriate 400-series temperature monitors.Interchangeability + 0.2oc at 37oc.Do not stretch catheter.This will cause repositioning of probe.Do not use stylet.This will cause stretching of catheter.Visually inspect the product for any imperfections or surface deterioration prior to use." 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 foley catheter was leaking and the nurse withdrew the water and there was only 8 cc of fluid in the balloon.She reinflated the balloon with 10 cc and the foley would not drain.She scanned the patient¿s bladder and found 200cc of residual urine.Per sample evaluation, it was noted that the catheter had an asymmetrical balloon which caused urine leakage.

• Brand Name: BARDEX® I.C. TEMPERATURE SENSING FOLEY CATHETER
• Type of Device: TEMPERATURE SENSING FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9945549
• MDR Text Key: 187604540
• Report Number: 1018233-2020-02496
• Device Sequence Number: 1
• Product Code: MJC
• UDI-Device Identifier: 00801741039775
• UDI-Public: (01)00801741039775
• Combination Product (y/n): N
• PMA/PMN Number: K040658
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 06/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 129416M
• Device Catalogue Number: 129416M
• Device Lot Number: MCDV5430
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/02/2020
• Date Manufacturer Received: 05/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1