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

Model Number	0119L20
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/06/2023
Type of Reportable Event	Malfunction
Additional 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.
Event or Problem Description
It was reported that the last time this occurred the foley balloon was over inflated, as too large a syringe was used causing extra pressure.This happened three times on the same patient.It was a dual lumen foley for irrigation and it was a yellow rubber material, not silicone like most of their foley catheters.A 10ml syringe was used but only 6 ml sterile water was drawn up in the syringe.The first catheter held water on test but ruptured on use but had only been inflated with approximately 3ml of water when it ruptured.The second foley balloon ruptured when tested and some pressure was applied before using on the patient.The third foley balloon was inspected visually and due to looking cracked or dry-rotted was not even tested based on the other failures.The packaging for the product indicated to inflate with 10ml in the balloon.
Additional Manufacturer Narrative
The reported event was inconclusive because no sample was returned.A potential root cause for this failure could be "inspection results (measurement, testing data) not verified by iqa assignee error of inspector".The provided lot number was invalid therefore dhr review can¿t be completed.The instructions for use were found adequate and state the following: ¿caution: this product contains natural rubber latex which may cause allergic reactions.Sterile unless package is opened or damaged.Warning: on catheter, do not use ointments or lubricants having petrolatum base.They will damage latex and may cause the balloon to burst.Caution: do not aspirate urine through drainage funnel wall.Storage: store catheters at room temperature away from direct exposure to light, preferably in the original box.Single patient use only.Do not reuse.Do not resterilize.For urological use only.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.Warning: after use, this product may be a potential biohazard.Handle and dispose of in accordance with applicable local, state, and federal laws and regulations.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 permitted by hospital protocol, the valve arm may be severed.If this fails, 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.Visually inspect the product for any imperfections or surface deterioration prior to use.¿ 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.
Event or Problem Description
It was reported that the last time this occurred the foley balloon was over inflated, as too large a syringe was used causing extra pressure, this happened three times on the same patient.It was a dual lumen foley for irrigation and it was a yellow rubber material, not silicone like most of their foley catheters.A 10ml syringe was used but only 6 ml sterile water was drawn up in the syringe.The first catheter held water on test but ruptured on use but had only been inflated with approximately 3ml of water when it ruptured.The second foley balloon ruptured when tested and some pressure was applied before using on the patient.The third foley balloon was inspected visually and due to looking cracked or dry-rotted was not even tested based on the other failures.The packaging for the product indicated to inflate with 10ml in the balloon.

• Brand Name: BARDEX® LUBRICATH® FOLEY CATHETER
• Common Device Name: 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: 16823303
• Report Number: 1018233-2023-02928
• Device Sequence Number: 12509370
• Product Code: EZC
• UDI-Device Identifier: 00801741019074
• UDI-Public: (01)00801741019074
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K910846
• 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
• Report Date (Section B): 09/15/2023

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 Model Number: 0119L20
• Device Catalogue Number: 0119L20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/06/2023
• Supplement Date Received by Manufacturer: 09/15/2023
• Initial Report FDA Received Date: 04/27/2023
• Supplement Report FDA Received Date: 09/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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