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

Catalog Number	0102L18
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/28/2024
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 customer had a recent issue.A patient was given a 5cc catheter to go home with, but that patient came back to the facility because it fell out.Staff noticed that the outer package listed a 5cc balloon, but printed on the physical catheter itself, it indicated to inflate with 10ml.Those differences caused concern for their clinicians, and they wanted to make sure this was not a mistake or confirm how the clinicians should be inflating these catheters.
Event or Problem Description
It was reported that customer had a recent issue.A patient was given a 5cc catheter to go home with, but that patient came back to the facility because it fell out.Staff noticed that the outer package listed a 5cc balloon, but printed on the physical catheter itself, it indicated to inflate with 10ml.Those differences caused concern for their clinicians, and they wanted to make sure this was not a mistake or confirm how the clinicians should be inflating these catheters.
Additional Manufacturer Narrative
The reported event was inconclusive.The conditions of the sample did not allow further evaluation.Visual evaluation of the returned two-photo sample noted one opened (without original packaging), used latex foley catheter.Visual inspection of the sample noted the first photo shows a overview of the inflation valve of the catheter.The second photo shows an overview of the catheter packaging with lot number, product number and product information.The recommended inflation capacities: 5cc balloon: use 10ml sterile water.The reported failure could not be evaluated therefore this investigation is considered inconclusive.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 ¿improper material specification improper compounding of raw material¿.However, there was insufficient information to confirm this potential root cause.A dhr review did not show any problems or conditions.The instructions for use were found adequate and state the following: "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 caution: this product contains natural rubber latex which may cause allergic reactions.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 caution: federal (u.S.A.) law restricts this device to sale by or on the order of a physician.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, reseat 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." udi format updated with available product information per gudid.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.

• Brand Name: BARDEX® LUBRICATH® FOLEY CATHETER TIEMANN MODEL COUDE
• 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 GA 30014
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 19546986
• Report Number: 1018233-2024-03503
• Device Sequence Number: 11974782
• Product Code: EZC
• UDI-Device Identifier: 00801741018138
• UDI-Public: (01)00801741018138(11)231106(17)271031(10)NGHX0639
• Combination Product (Y/N): N
• Initial Reporter State: NM
• 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,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/13/2024

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: 0102L18
• Device Lot Number: NGHX0639
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/28/2024
• Supplement Date Received by Manufacturer: 09/13/2024
• Initial Report FDA Received Date: 06/17/2024
• Supplement Report FDA Received Date: 09/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/06/2023
• 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