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

Catalog Number	123620A
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/03/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that they had 3 instances over the past couple of weeks with catheters that seem to have a faulty balloon.2 of these patients have had to go to the er to have the catheter removed and the physicians in the er were also unable to deflate the balloon.One of them had to have a procedure to remove it and the other they were able to cut the catheter and eventually the balloon deflated.The er physician stated that they were perplexed as to why the balloon would not deflate.The 3rd patient was going to the er today as his was still draining and they did not want to go last night.2 of these catheters are the same brand and item number ¿ bard 18fr 802318.They were unable to find a lot number in mckesson to see if they were the same.The 3rd patient also had a bard 20 french with 30cc balloon 802320.They were concerned that there may be a faulty lot number.They did not want patients having to go to the er and have procedures that are unnecessary when they are already experiencing health issues.Same brand and item number ¿ bard 18fr 802318.They were unable to find a lot number in mckesson to see if they were the same.The 3rd patient also had a bard 20 french with 30cc balloon 802320.They were concerned that there may be a faulty lot number.They did not want patients having to go to the er and have procedures that are unnecessary when they are already experiencing health issues.
Additional Manufacturer Narrative
The reported event was inconclusive because no sample was returned.The potential root cause for this failure could be user related (example: over aspirated, incorrect syringe/collapse lumen/sac close eye/valve damage).A potential root cause for this failure mode could be, thin rubberize wall that causing collapse/pinch inflation lumen under the balloon or along the shaft.The device was not returned for evaluation.The dhr review could not be performed without a lot number.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 a petrolatum base.They will damage latex and may cause balloon to burst.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 syringe.Do not use needle.Visually inspect the product for any imperfections or surface deterioration prior to use.Do not use if package is opened or damaged.Recommended inflation capacities: 5cc balloon: use 10cc sterile water.30cc balloon: use 35cc sterile water.Do not exceed recommended capacities.Note: after use, this product may be a potential biohazard.Handle and dispose of in accordance with accepted medical practice and applicable laws and regulations.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 an 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." 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 had 3 instances over the past couple of weeks with catheters that seem to have a faulty balloon.2 of these patients have had to go to the er to have the catheter removed and the physicians in the er were also unable to deflate the balloon.One of them had to have a procedure to remove it and the other they were able to cut the catheter and eventually the balloon deflated.The er physician stated that they were perplexed as to why the balloon would not deflate.The 3rd patient was going to the er today as his was still draining and they did not want to go last night.2 of these catheters are the same brand and item number ¿ bard 18fr 802318.They were unable to find a lot number in mckesson to see if they were the same.The 3rd patient also had a bard 20 french with 30cc balloon 802320.They were concerned that there may be a faulty lot number.They did not want patients having to go to the er and have procedures that are unnecessary when they are already experiencing health issues.Same brand and item number ¿ bard 18fr 802318.They were unable to find a lot number in mckesson to see if they were the same.The 3rd patient also had a bard 20 french with 30cc balloon 802320.They were concerned that there may be a faulty lot number.They did not want patients having to go to the er and have procedures that are unnecessary when they are already experiencing health issues.
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.

• 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: 19371034
• Report Number: 1018233-2024-02891
• Device Sequence Number: 7689189
• Product Code: KOD
• UDI-Device Identifier: 00801741095214
• UDI-Public: (01)00801741095214
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K922431
• 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): 06/19/2024

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: 123620A
• 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: 05/03/2024
• Supplement Date Received by Manufacturer: 06/19/2024
• Initial Report FDA Received Date: 05/22/2024
• Supplement Report FDA Received Date: 06/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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