MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARDIA® FOLEY CATHETER SILICONE COATED

Catalog Number	123514A
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/09/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported event was confirmed ¿ cause unknown.Based on the attached photo, it was observed that the balloon was burst.However, the exact cause of how and when the problem occurred could not be determined.No further testing could be conducted due to only photo sample is provided.A potential root cause for this failure could be for this failure mode could be user related (example: contact with sharp object/ exposure to petrolatum based products mechanical failure/operator error).A review of the device history record did not show any problems or conditions that would have contributed to the reported issue.Therefore, no additional action required at this time.The instructions for use were found adequate and state the following: warning: do not use ointments or lubricants having a petroleum, they will damage latex and may cause balloon to burst.Do not aspirate urine through the drainage funnel wall.Visually inspect the product for any imperfections or surface deterioration prior to use.Use luer tip syringe to inflate with stated ml/cc od sterile water.Do not use needle or for prefilled product, remove clip and squeeze reservoir to inflate with stated ml/cc of sterile water.Recommend inflation capacities: 5ml/cc balloon: use 10ml/cc sterile water; 30ml/cc balloon: use 35ml/cc sterile water; do not exceed recommended capacities.For urological use only.To deflate catheter balloon, gently insert 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 professionals for assistance as directed by hospital protocol.Should balloon rupture occurred care should be taken to assure that all balloon fragments have been removed from the patient.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 they checked foley place, found that foley catheter balloon was ruptured and foley slide out.
Event or Problem Description
It was reported that they checked foley place, found that foley catheter balloon was ruptured and foley slide out.
Additional Manufacturer Narrative
The reported event was confirmed ¿ cause unknown.The reported failure was able to be reproduced.The product was used for urological care.Evaluation confirmed the balloon was rupture with missing pieces.The missing pieces was not returned.However, the exact cause of how and when the problem occurred could not be determined.The potential root cause for this failure could be user related (example: contact with sharp object)/ exposure to petrolatum based products/ mechanical failure/operator error).A review of the device history record did not show any problems or condition 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 petroleum, they will damage latex and may cause balloon to burst.Do not aspirate urine through the drainage funnel wall.Visually inspect the product for any imperfections or surface deterioration prior to use.Use luer tip syringe to inflate with stated ml/cc od sterile water.Do not use needle or for prefilled product, remove clip and squeeze reservoir to inflate with stated ml/cc of sterile water.Recommend inflation capacities: 5ml/cc balloon: use 10ml/cc sterile water 30ml/cc balloon: use 35ml/cc sterile water.Do not exceed recommended capacities.For urological use only.To deflate catheter balloon, gently insert 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 adequate trained professionals for assistance as directed by hospital protocol.Should balloon rupture occurred care should be taken to assure that all balloon fragment have been removed from the patient." correction: d, h.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.

• Brand Name: BARDIA® FOLEY CATHETER SILICONE COATED
• 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: 20087986
• Report Number: 1018233-2024-05256
• Device Sequence Number: 7580858
• Product Code: EZC
• UDI-Device Identifier: 00801741171673
• UDI-Public: (01)00801741171673(11)240208(17)281028(10)MYHZ1488
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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): 10/30/2024

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: 123514A
• Device Lot Number: MYHZ1488
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/09/2024
• Supplement Date Received by Manufacturer: 10/30/2024
• Initial Report FDA Received Date: 08/28/2024
• Supplement Report FDA Received Date: 11/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/08/2024
• 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