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

Catalog Number 0165L16

Device Problem Material Puncture/Hole (1504)

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

Event Date 03/11/2024

Event Type  malfunction  

Event Description

It was reported that when the user tried to insert the foley catheter, the sterile water leaked from around the balloon area.A new catheter was prepared and placed without any problems.Per additional information received on 14mar2024, the product was not used in the patient.

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.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.

Manufacturer Narrative

The reported event was confirmed ¿ unknown cause.The catheter was inspected and observed tear on balloon sac.However, the exact cause of how and when the problem occurred could not be determined.As per the reported event, the patient had history of stones.The potential root cause for this failure mode could be due to incorrect sac fitting technique/sharp end of sac fit tool/damaged sac after unloading from sac manufacturing machine/rough handling of dipped sac former or user related.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) do not inflate the balloon in the urethra.[the ur eth ra may be injured.] (2) do not pull the catheter hard.[ t he bladder/urethra may be injure d 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) 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.] (4) 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 shape, configuration and principle s bardia ® b iocath ® foley catheter is a balloon catheter.The re are different type variations, for example, 2way and 3way products.Some may include a syringe prefilled with sterile water and a water soluble lubricant as an accessory.Material: balloon catheter: natural rubber latex sizes of catheters: available in sizes 12 to 26 every 2fr 1.Balloon catheter 2.Accessories syringe prefilled with sterile watered with sterile water.Water--soluble lubricant soluble lubricant (neither of them neither of them may be included in some product variations).May be included in some product variations.) [intended use & effect-- efficacy]efficacy]: this device designed to be placed in the bladder designed to be placed in the bladder for the purpose of urinary drainage and for the purpose of urinary drainage and bladder irrigation bladder irrigation.[[directions for use directions for use]]: 1.Method of use method of use the device is intended for single use only and is not reusable.1) cleanse the area around the external urethral cleanse the area around the external urethral memeatus with the cotton balls immersed immersed in the antiseptics.2) lubricate lubricate the distal end of the the distal end of the catheter with waterer with water--soluble lubricant.Soluble lubricant.3) insert catheter into the urethral meatus and advance it until the balloon enters the insert catheter into the urethral meatus and advance it until the balloon enters the bladder and urine flows out through bladder and urine flows out through the catheter.Using a needle the catheter.Infuse the specified volume of sterile water into the infuse the specified volume of sterile water into the inflation lumen to inflate the inflation lumen to inflate the balloon.4) pull catheter to seat the balloon at the level of the bladder neck and secure pull catheter to seat the balloon at the level of the bladder neck and secure placement.[storage method and expiration date]and expiration date]: 1.Storage: store in a dry, cool place away.Store in a dry, cool place away from heat, from heat, moisture , and direct sunlight, and direct sunlight.2.Expiration date: indicated on the direct package and the outer box." the reported event was confirmed ¿ unknown cause.The catheter was inspected and observed tear on balloon sac.However, the exact cause of how and when the problem occurred could not be determined.As per the reported event, the patient had history of stones.The potential root cause for this failure mode could be due to incorrect sac fitting technique/sharp end of sac fit tool/damaged sac after unloading from sac manufacturing machine/rough handling of dipped sac former or user related.H3 other text : the actual/suspected device was inspected.

Event Description

It was reported that when the user tried to insert the foley catheter, the sterile water leaked from around the balloon area.A new catheter was prepared and placed without any problems.Per additional information received on 14mar2024, the product was not used in the patient.

Event Description

It was reported that when the user tried to insert the foley catheter, the sterile water leaked from around the balloon area.A new catheter was prepared and placed without any problems.Per additional information received on 14mar2024, the product was not used in the patient.Per additional information received on 10apr2024, it was reported that the product was used in the patient.

Manufacturer Narrative

The reported event was confirmed ¿ unknown cause.The catheter was inspected and observed tear on balloon sac.However, the exact cause of how and when the problem occurred could not be determined.As per the reported event, the patient had history of stones.The potential root cause for this failure mode could be due to incorrect sac fitting technique/sharp end of sac fit tool/damaged sac after unloading from sac manufacturing machine/rough handling of dipped sac former or user related.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) do not inflate the balloon in the urethra.[the ur eth ra may be injured.] (2) do not pull the catheter hard.[ t he bladder/urethra may be injure d 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) 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.] (4) 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 shape, configuration and principle s bardia ® b iocath ® foley catheter is a balloon catheter.The re are different type variations, for example, 2way and 3way products.Some may include a syringe prefilled with sterile water and a water soluble lubricant as an accessory.< material > balloon catheter: natural rubber latex sizes of catheters > available in sizes 12 to 26 every 2fr 1.Balloon catheter 2 2.Accessories syringe prefilled with sterile watered with sterile water--soluble lubricant soluble lubricant (neither of them neither of them may be included in some product variations.)may be included in some product variations.) [intended use & effect [intended use & effect-- efficacy]efficacy] this dev this device designed to be placed in the bladder designed to be placed in the bladder for the purpose of urinary drainage and for the purpose of urinary drainage and bladder irrigation bladder irrigation.[[directions for use directions for use]] 1.Method of use method of use the device is intended for single use only and is not reusable.(1)1) cleanse the area around the external urethral cleanse the area around the external urethral memeatus with the cotton balls immersed in the antiseptics.(2)2) lubricate the distal end of the distal end of the catheter with waterer with water--soluble lubricant.Soluble lubricant.(3)3) insert catheter into the urethral meatus and advance it until the balloon enters the insert catheter into the urethral meatus and advance it until the balloon enters the bladder and urine flows out through bladder and urine flows out through the catheter.Using a needle the catheter.Infuse the specified volume of sterile water into the infuse the specified volume of sterile water into the inflation lumen to inflate the inflation lumen to inflate the balloon.(4)4) pull catheter to seat the balloon at the level of the bladder neck and secure pull catheter to seat the balloon at the level of the bladder neck and secure placement.[storage method and expiration date]and expiration date] 1.Storage store in a dry, cool place away store in a dry, cool place away from heat, from heat, moisture , and direct sunlight, and direct sunlight.2.Expiration date expiration date indicated on the direct package and the outer box." 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.

• 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: 18992993
• MDR Text Key: 338891304
• Report Number: 1018233-2024-01689
• 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,Followup,Followup
• Report Date: 04/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0165L16
• Device Lot Number: MYHV1724
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/15/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/29/2023
• 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