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

Catalog Number 129414M

Device Problems Deflation Problem (1149); No Flow (2991); Physical Resistance/Sticking (4012)

Patient Problems Injury (2348); Patient Problem/Medical Problem (2688)

Event Date 06/22/2020

Event Type  Injury  

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 balloon was stuck in the prostate gland and there was damage to the urethra.No urine flow was observed and it was difficult to deflate.Eventually the balloon was burst with the needle under the scrotum and the catheter was removed.Per additional information received via email on 08jul2020 from ibc representative, there was no urine when the catheter was inserted in the patient that was the reason for removal of the catheter.

Event Description

It was reported that the balloon was stuck in the prostate gland and there was damage to the urethra.No urine flow was observed and it was difficult to deflate.Eventually the balloon was burst with the needle under the scrotum and the catheter was removed.Per additional information received via email on 08jul2020 from ibc representative, there was no urine when the catheter was inserted in the patient that was the reason for removal of the catheter.

Manufacturer Narrative

The reported event was confirmed as manufacturing-related.Sample was evaluated and inflation eye met internal specification.Subsequent investigation show strong correlation of low rubberize layer in combination with high x-sectional ratio as primary contributor to collapsed lumen failure during usage by user.Potential root cause for this failure mode could be rubberize thickness variation and low latex viscosity.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: "[warnings] 1.Method for use 1.Method of use the device is intended for single use only and is not reusable.(1) to secure a sterile field for the procedure, spread a clean wrapping paper.(2) place waterproof sheet beneath patient¿s buttocks.(fig.1) (3) put on sterile gloves.Open tray and place it on the wrapping paper.(fig.2) (4) cleanse the area around the external urethral meatus with the cotton balls immersed in the antiseptics.(fig.3) (5) lubricate the distal end of the catheter with water-soluble lubricant packaged in the tray.(fig.4) (6) insert catheter into the urethral meatus, and advance it until the balloon enters the bladder and urine flows out through the catheter.Using a syringe packaged in the tray, infuse the specified volume of sterile water into the inflation lumen to inflate the balloon.(fig.5) (7) pull catheter to seat the balloon at the level of the bladder neck and secure placement.(8) keep the drainage bag below the bladder level without touching the floor.(fig.6) (9) secure drainage tube to bed sheet with clip to ensure that there is neither twist nor kink in the tube.(fig.7) (10) to deflate balloon and remove catheter, insert a luer tip (needleless) syringe in the inflation valve to allow the water drain spontaneously.After balloon deflation, withdraw the catheter while confirming that no resistance is encountered.Direction for use 1) occlude drainage tubing a minimum of 10 cm below the sampling port by kinking the tubing until urine fills the tubing up to near (slightly above) the sampling port.2) swab surface of site with antiseptic wipe.3) using aseptic technique, position the needle-less syringe (slip-tip type or luer-lock type) in the center of the sampling port.The syringe should be held perpendicular to the surface of the sampling port.Press the syringe and twist to lock the syringe onto the sampling port.(fig.8) 4) aspirate desired volume of urine.After sampling, detach the syringe.Ensure that the rubber stem of the sampling port has returned to its original position.5) unkink tubing." 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.

• Brand Name: BARDEX I.C. TEMPERATURE SENSING FOLEY CATHETER
• Type of Device: TEMPERATURE SENSING CATHETER (LATEX)
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 10270991
• MDR Text Key: 198762837
• Report Number: 1018233-2020-04497
• Device Sequence Number: 1
• Product Code: MJC
• Combination Product (y/n): N
• PMA/PMN Number: K910318
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Type of Report: Initial,Followup
• Report Date: 10/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2023
• Device Catalogue Number: 129414M
• Device Lot Number: 9RS123
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/03/2020
• Date Manufacturer Received: 09/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention