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

Catalog Number 129414M

Device Problem Decrease in Pressure (1490)

Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/06/2021

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 water leaked from the catheter during pretest.

Event Description

It was reported that water leaked from the catheter during the pretest.

Manufacturer Narrative

The reported event was confirmed as a manufacturing related.The device did not meet the specifications and was influenced by the reported failure.The root cause for this failure mode was due to bubble void on the rubberize layer which caused the lumen to lumen leakage.A review of the manufacturing process indicates that the process was capable of producing of this type of defect.The device history record was reviewed and found a possible manufacturing issue 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) do not inflate the balloon in the urethra.[the urethra may be injured.] (2) do not pull the catheter hard.[the bladder or urethra may be injured.] 2.Applicable patients with delirium who might pull out catheter [when patient tugs at catheter unconsciously, the bladder and urethra may be damaged.] [contraindications]; 1.Method for use: (1) do not reuse.(2) do not resterilize.(3) this device contains 10 percent povidone iodine.For patients with past history of allergic hypersensitivity to povidone iodine or iodine, consider using alternative disinfectants.(4) be careful that the catheter is not exposed to ointments, contrast medium or oil based lubricants (including vegetable oils such as olive oil, mineral oils such as white petrolatum and animal oils).[they may damage the device and may burst balloon.] (5) do not hold the device with forceps, etc.Avoid contact with any blades or sharp edged instruments.[catheter damage may cause balloon rupture and accidental balloon removal or failure to deflate or remove the balloon.] 2.Applicable patients: (1) patients who are or have been allergic to natural rubber latex.(2) patients with known allergy to silver coated catheter.[intended use & effect- efficacy]: the device is a tray kit product that is used for the purpose of urinary drainage and measurement of core body temperature.It combines a balloon catheter with temperature-sensing designed to be placed in the bladder, and a urinary drainage bag.[directions for use]: 1.Method of use the device is intended for single use only and is not reusable.2.Precautions for use 1) to secure a sterile field for the procedure, spread a clean wrapping paper.2) place waterproof sheet beneath patients buttocks.3) put on sterile gloves.Open tray and place it on the wrapping paper.4) cleanse the area around the external urethral meatus with the cotton balls immersed in the antiseptics.5) lubricate the distal end of the catheter with water-soluble lubricant packaged in the tray.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.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.9) connect the lead wire of catheter to temperature monitor with extension cable.10) secure drainage tube to bed sheet with clip to ensure that there is neither twist nor kink in the tube.11) 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." 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 I.C. TEMPERATURE SENSING FOLEY CATHETER
• Type of Device: FOLEY CATHETER (LATEX)
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 11378167
• MDR Text Key: 233483323
• Report Number: 1018233-2021-00791
• 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: other,user facility
• Type of Report: Initial,Followup
• Report Date: 04/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/28/2023
• Device Catalogue Number: 129414M
• Device Lot Number: MYEU2802
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2021
• Date Manufacturer Received: 04/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other