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

Catalog Number	0165L24
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/22/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that customer did not want to use the device due to a series of unremovable incidents of foley catheter.There was no reported patient involvement.
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The reported product number is sold ous.The udi number for this product is not available.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.
Additional Manufacturer Narrative
The reported event was unconfirmed because the reported failure could not be reproduced.The product had not caused the reported failure.No root cause could be found because the reported event was unconfirmed.A potential root cause for this failure mode could be, thin rubberize wall that causing collapse/pinch inflation lumen under the balloon or along the shaft.Based on information in the pfmea, the risk of this failure is medium.Current controls in place are adequate to mitigate this failure mode.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: "single use only 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 restabilize.(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 shape, configuration and principles bard i.C.Foley tray b consists of a balloon catheter, urine-collecting bag for closed drainage system, syringe prefilled with sterile water, water-soluble lubricant, antiseptic solution, waterproof sheet, tweezers, gauze pads, cotton balls, and vinyl gloves.There are two types of catheters, two way and three way, and several types of closed drainage bags.The catheter and/or bag included in the tray will depend on the product.Materia balloon catheter: natural rubber latex sizes of catheters available in sizes 8 to 24 every 2fr 1.Foley catheter 2.Accessories closed drainage bag the illustration shows one example of typical configurations.Syringe prefilled with sterile water water soluble lubricant antiseptics: bard® 10 percentage povidone-iodine solution tweezers gauze pads waterproof sheet cotton balls gloves 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.Directions 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.(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." this report references a us equivalent device.The us udi equivalent for this product number is used 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.
Event or Problem Description
It was reported that customer did not want to use the device due to a series of unremovable incidents of foley catheter.There was no reported patient involvement.

• Brand Name: BARDEX® LUBRICATH® FOLEY CATHETER
• Common Device Name: FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 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: 19974423
• Report Number: 1018233-2024-04869
• Device Sequence Number: 8460737
• Product Code: EZC
• UDI-Device Identifier: 00801741017520
• UDI-Public: (01)00801741017520(11)240320(17)280628(10)MYHZ2995
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K910846
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 0165L24
• Device Lot Number: MYHZ2995
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/22/2024
• Supplement Date Received by Manufacturer: 09/04/2024
• Initial Report FDA Received Date: 08/13/2024
• Supplement Report FDA Received Date: 09/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/20/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown