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

Catalog Number	0102L16
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	02/09/2024
Type of Reportable Event	Serious Injury
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.H3 other text : the device was not returned.
Event or Problem Description
It was reported that the foley catheter was put in place, the balloon was filled and the procedure that need to take place was completed.Once complete with the procedure, the attending staff went through the process of deflating the balloon and the balloon would not deflate.The doctor tried cutting the end of the catheter to see if balloon would deflate so they could pull the catheter out and it did not.At that point, in order to get the catheter to deflate, the doctor used a laser to puncture the balloon which allowed it to deflate and they were able to pull it out.They asked for all product to be removed and an iris written for the incident and had removed all of the product from short stay (16 ea.) and have them in their office.There were 2 different lot numbers.There were a quantity of 11 with lot number (lot #nghw0803) and a quantity of 5 with lot number (lot #nghw2914).
Additional Manufacturer Narrative
The reported event was inconclusive because no sample was returned.A potential root cause for this failure could be ¿¿inadequate material selection / inflation lumen collapses ¿.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: "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 foley catheter was put in place, the balloon was filled and the procedure that need to take place was completed.Once complete with the procedure, the attending staff went through the process of deflating the balloon and the balloon would not deflate.The doctor tried cutting the end of the catheter to see if balloon would deflate so they could pull the catheter out and it did not.At that point, in order to get the catheter to deflate, the doctor used a laser to puncture the balloon which allowed it to deflate and they were able to pull it out.They asked for all product to be removed and an iris written for the incident and had removed all of the product from short stay (16 ea.) and have them in their office.There were 2 different lot numbers.There were a quantity of 11 with lot number (lot #nghw0803) and a quantity of 5 with lot number (lot #nghw2914).

• Brand Name: BARDEX® LUBRICATH® FOLEY CATHETER TIEMANN MODEL COUDE
• Common Device Name: LATEX RED RUBBER 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: 18815503
• Report Number: 1018233-2024-01073
• Device Sequence Number: 11843421
• Product Code: EZC
• UDI-Device Identifier: 00801741018121
• UDI-Public: (01)00801741018121
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 03/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 0102L16
• Device Lot Number: NGHW2914
• 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: 02/09/2024
• Supplement Date Received by Manufacturer: 03/13/2024
• Initial Report FDA Received Date: 03/01/2024
• Supplement Report FDA Received Date: 03/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/24/2023
• 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: Required Intervention
• Patient Sex: Unknown