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

Catalog Number	0167L18
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/10/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that an 18 fr foley catheter was inserted into a patient with a 30cc balloon and the fluid was unable to withdraw from the luer lock.The catheter was cut to release fluid and the fluid was removed.The bulb was found to be burst, and all parts were intact upon removal.
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.
Event or Problem Description
It was reported that an 18 fr foley catheter was inserted into a patient with a 30cc balloon and the fluid was unable to withdraw from the luer lock.The catheter was cut to release fluid and the fluid was removed.The bulb was found to be burst, and all parts were intact upon removal.
Additional Manufacturer Narrative
The reported event was inconclusive because no sample was available for evaluation and further investigation did not result in any additional findings.Root cause could not be identified.Although a root cause could not be definitively identified, based on the risk documentation review, a potential root cause for this type of failure could be ¿inadequate valve design".However, there was insufficient information to confirm this potential root cause.A review of the device history record did not show any problems or conditions that would have contributed to the reported issue.The instructions for use were found adequate and state the following: "warning: do not use ointments or lubricants having a petrolatum base.They will damage the catheter.English units this is a single use device.Do not resterilize any portion of this device.Reuse and/or repackaging may create a risk of patient or user infection, compromise the structural integrity.And/or essential material and design characteristics of the device, which may lead to device.Failure, and/or lead to injury, illness or death of the patient.Visually inspect the product for any imperfections or surface deterioration prior to use.Use luer tip syringe to inflate with stated ml of sterile water.Or for pre-filled products, remove clip and squeeze reservoir to inflate with stated ml of sterile water.Storage: store catheters at room temperature away from direct exposure to light, preferably in the original box.For urological use only.Do not use if package is damaged.Bard, bardex, and lubricath are trademarks and/or registered trademarks of c.R.Bard, inc.Single use do not resterilize.Manufacturer: to deflate catheter balloon: gently insert a luer slip tip syringe in the catheter valve.Never use.More force than is required to make the syringe "stick" in the valve.Allow the pressure within the balloon to force the plunger back and fill the syringe with water.If you notice slow or no deflation, re-seat the syringe gently.Use only gentle aspiration to encourage deflation if needed.Vigorous aspiration may collapse the inflation lumen, preventing balloon deflation.If necessary, contact adequately trained professional for assistance, as directed by hospital protocol.Should balloon rupture occur, care should be taken to assure that all balloon fragments.Have been removed from the patient.Contains or presence of natural rubber latex.Caution: this product contains natural rubber latex which may cause allergic reactions.Keep away from sunlight.Valve type: use luer slip tip syringe.Do not use needle.Recommended inflation capacities: 3cc balloon: use 5ml sterile water; 5cc balloon: use 10ml sterile water; 15cc balloon: use 20ml sterile water; 20cc balloon: use 25ml sterile water; 30cc balloon: use 35ml sterile water; 40cc balloon: use 45ml sterile water; 75cc balloon: use 80ml sterile water; do not exceed recommended capacities.Refer to direct unit label for sterilization method utilized.Sterilized by radiation sterilized by ethylene.Or oxide.Warning: after use, this product may be a potential biohazard.Handle and dispose of in accordance with accepted medical practice and applicable laws and regulations." 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 inconclusive because no sample was available for evaluation and further investigation did not result in any additional findings.The reported event is addressed within the labeling as it states: to deflate catheter balloon: gently insert a luer slip tip syringe in the catheter valve.Never use more force than is required to make the syringe ¿stick¿ in the valve.Allow the pressure within the balloon to force the plunger back and fill the syringe with water.If you notice slow or no deflation, re seat the syringe gently.Use only gentle aspiration to encourage deflation if needed.Vigorous aspiration may collapse the inflation lumen, preventing balloon deflation.If necessary, contact adequately trained professional for assistance, as directed by hospital protocol.A review of the device history record did not show any problems or conditions that would have contributed to the reported issue.No actions can be taken at this time since a root cause was not identified.Corrections: d, e, f, h.Udi format updated with available product information per gudid.H11: sections 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 an 18 fr foley catheter was inserted into a patient with a 30cc balloon and the fluid was unable to withdraw from the luer lock.The catheter was cut to release fluid and the fluid was removed.The bulb was found to be burst, and all parts were intact upon removal.

• 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 GA 30014
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 19417002
• Report Number: 1018233-2024-03094
• Device Sequence Number: 15595367
• Product Code: KOD
• UDI-Device Identifier: 00801741018954
• UDI-Public: (01)00801741018954(11)240131(17)271130(10)NGHZ2491
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K922431
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/28/2026

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: 0167L18
• Device Lot Number: NGHZ2491
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/10/2024
• Supplement Date Received by Manufacturer: 06/19/2024; 04/28/2026
• Initial Report FDA Received Date: 05/29/2024
• Supplement Report FDA Received Date: 06/20/2024; 04/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/31/2024
• 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