MAUDE Adverse Event Report: C.R. BARD INC. (COVINGTON) -1018233 BARDEX® LUBRICATH® FOLEY CATHETER

Catalog Number 0165L14

Device Problem Inaccurate Flow Rate (1249)

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

Event Date 03/05/2024

Event Type  malfunction  

Event Description

It was reported that recently, a patient with a bladder catheter in place did not have urine flow, and when the fixed water was drained to replace the catheter, there was an incident report that 22 of fixation water was contained in the catheter.It was found that there was usually a habit of increasing the amount of fixed water in patients with urine leakage and checking their condition.Fixation water was fixed at 10 and may decrease slightly during insertion, in which case the amount of fixation water should be checked and if it was small, the user would be aware that they would put in 10 again.They thought that there was also the fear that the balloon would burst if fixed water was increased.Moreover, the fact that it was increased was not stated anywhere, etc.It was a series of problems.

Manufacturer Narrative

The reported event was inconclusive because no sample was returned.It is unknown whether the device had met relevant specifications.The potential root cause for this failure could be user related (example: salt accumulation)/block drainage lumen/no drainage eye).The dhr review is not required as the lot number is unknown.The instructions for use were found adequate and states 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/urethra may be injured.] 2.Applicable patients: (1) 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% 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) do not use in patients who are or have been allergic to natural rubber latex [intended use & effect- efficacy] the device combines an indwelling bladder catheter and a urinary drainage bag that are used for urinary drainage and bladder irrigation.[precautions] 1.Precautions for use (exercise caution when using the device in the following patients) (1) exercise caution when using the device in patients with high urinary calcium levels as encrustation on the balloon surface, catheter occlusion or damage may occur.2.Important precautions: (1) when catheter is inadvertently removed, inspect the balloon and shaft of catheter for rupture, defect, etc.Before inserting a new catheter.(2) when any part of the balloon and/or the catheter is missing, consider removing them using a cystoscope.(3) when it is difficult to remove catheter by deflating the balloon, take appropriate measures according to the section ¿troubleshooting¿.3.Malfunction and adverse events 1) malfunction: - catheter kinking, damage, rupture, - difficulty or failure to remove the device, - occlusion of catheter inner lumens, - encrustation, - accidental removal of the device due to leakage of sterile water or balloon rupture, - device damage due to inappropriate use.2) adverse events: - urinary-tract infection, - hemorrhage, hematuria, - allergy reaction to the device, - calculus formation, - edema, - pain, - discomfort, - injury of bladder or urethral, - urethritis, urinary incontinence, - retained balloon fragments.[storage method and expiration date] 1.Storage: store in a dry, cool place away from heat, moisture, and direct sunlight.2.Expiration date: indicated on the direct package and the outer box." h11: section a through f - 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.H3 other text : the device was not returned.

• Brand Name: BARDEX® LUBRICATH® FOLEY CATHETER
• Type of Device: 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: 18929257
• MDR Text Key: 337990172
• Report Number: 1018233-2024-01416
• Device Sequence Number: 1
• Product Code: EZC
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K910846
• 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
• Report Date: 03/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0165L14
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/05/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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