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

Catalog Number	365714
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/06/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the foley catheter balloon was defective.The lot number was unknown as packaging was not saved (batch# unk).The office had four different lot numbers (batch# myft1395, batch# mygz4197, batch# mygz4503 and batch# mygq6715).Per follow up via email on 13sep2023, it was reported that it was the same patient, an older male palliative client (95 years of age).The catheter balloons reportedly blew while inside their bladder (two catheters reported having the same issue) catheters were out, and daughter placed them in bag for the nurses to see.There were no further medical interventions done.It seemed no harm was done.Attending nurse replaced the catheter.They temporarily pulled all size 14 fr.Catheters off the shelf as they did not know the lot numbers of those two catheters.They tested few other catheters same size different batches and they all look fine.
Additional Manufacturer Narrative
The reported event was inconclusive because no sample was returned.However, the potential root cause for this failure mode could be user related (example: contact with sharp object)/ exposure to petrolatum based products/ mechanical failure/ operator error.A potential root cause for this failure mode could be due to thin sac that may lead to burst balloon.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: "burst balloon: a review of the device labeling is adequate to prevent the reported event.Do not use ointments or lubricants having a petrolatum base.They will damage latex and may burst balloon.Premature deflation: caution: this product contains natural rubber latex.Which may cause allergic reactions.Pk6194321 4/03 rev.0 sterile unless package is opened or damaged.Do not use if package is opened or damaged.Warning: on catheter, do not use ointments or lubricants having a petrolatum base.They will damage latex and may cause balloon burst.Balloon burst can lead to premature deflation.Inaccurate flowrate: a review of the device labeling is adequate to prevent the reported event.Visually inspect the product for any imperfections or surface deterioration prior to use.Leak around the meatus: "visually inspect the product for any imperfections or surface deterioration prior to use.Recommended inflation capacities.3cc balloon: use 5cc sterile water.5cc balloon: use 10cc sterile water.15cc balloon: use 20cc sterile water.20cc balloon: use 25cc sterile water.30cc balloon: use 35cc sterile water.40cc balloon: use 45cc sterile water.75cc balloon: use 50cc sterile water.Do not exceeded recommended capacities." non deflator: to deflate catheter balloon: gently insert a syringe in the catheter valve.Never use more force than is required to make the syringe "stick" in the valve.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 and adequately trained professional for assistance, as directed by hospital protocol." 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.

• Brand Name: BARD® 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: 17798291
• Report Number: 1018233-2023-07000
• Device Sequence Number: 7041628
• Product Code: EZC
• UDI-Device Identifier: 00801741077739
• UDI-Public: (01)00801741077739
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K910846
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/18/2023

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 Catalogue Number: 365714
• Device Lot Number: MYGQ6715
• 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: 09/07/2023
• Initial Report FDA Received Date: 09/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2022
• 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: Male