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

Model Number	0165SI24
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Chest Pain (1776)
Date of Event	05/21/2021
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.
Event or Problem Description
It was reported that the 24 fr bardex ic foley catheter was not draining about 2 weeks after being changed.The user had cut the tip off and inflated balloon of the catheter but there was no obstruction found.Customer stated that one or two had happened using the catheter and two more were reported in patients home changes, where one was with lot number ngex487 and for the other they did not have the lot number.The user did few sleuthing like cutting the tip off and inflated balloon of the 2-week-old catheter where the balloon material had occluded the inner lumen of the catheter and no longer was draining.Per additional information received via email on (b)(6) 2021 customer stated that at least 7 patients had similar issues and all the patients had been using the 24 fr bardex ic foley catheters.Stated that the foley catheter quit draining.When the user attempted to irrigate, they could get water to flush in, but they could not get any to drain back out.The catheter drained fine only when they deflated the balloon for exchange.This had happened with patients getting exchanged in their home as well as for patients getting exchanged in the clinics.Most of the time, patients were noticing the issue about 2-3 weeks after the exchange.Also, customer stated that the lumen of the catheter was clearly shown to be blocking when they re-inflated the balloon that was removed from the patient after 2 weeks.Customer stated that the lot number reported in home changes was also the same lot number currently being used in the hospital.Per follow up via email on (b)(6) 2021, customer reported that they were only having issues with the 24 fr bardex catheters and the issues were with various lots.Each case happened at almost exactly 2 weeks after the catheter was inserted.Per additional information received on (b)(6) 2021 customer had another defective foley on (b)(6) 2021.
Additional Manufacturer Narrative
The reported event was inconclusive because no sample was returned.No potential root could be concluded due to insufficient information.The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: ''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 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.Visually inspect the product for any imperfections or surface deterioration prior to use.Valve type: use luer slip syringe.Do not use needle.Recommended inflation capacities: - 3cc balloon: use 5cc sterile water - 5cc balloon: use 10cc sterile water - 30cc balloon: use 35cc sterile water 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.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 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 the 24 fr bardex ic foley catheter had not drained for about 2 weeks after being changed.The user had to cut the tip off and inflated balloon of the catheter but there was no obstruction found.Customer stated that one or two happened using the catheter and two more were reported in patients home changes, where one was with lot number ngex487 and for the other they did not have the lot number.The user did few sleuthing like cutting the tip off and inflated balloon of the 2-week-old catheter where the balloon material had occluded the inner lumen of the catheter and no longer was draining.Per additional information received via email on 02apr21, customer stated that at least 7 patients had similar issues and all the patients had been using the 24 fr bardex ic foley catheters.Stated that the foley catheter quit draining.When the user attempted to irrigate, they could get water to flush in, but they could not get any to drain back out.The catheter drained fine only when they deflated the balloon for exchange.This had happened with patients getting exchanged in their home as well as for patients getting exchanged in the clinics.Most of the time, patients were noticing the issue about 2-3 weeks after the exchange.Also, customer stated that the lumen of the catheter was clearly shown to be blocking when they re-inflated the balloon that was removed from the patient after 2 weeks.Customer stated that the lot number reported in home changes was also the same lot number currently being used in the hospital.Per follow up via email on 14apr2021, customer reported that they were having issues with the 24 fr bardex catheters and the issues were with various lots.Each case happened at almost exactly 2 weeks after the catheter was inserted.Per additional information received on 21may2021, customer had another defective foley on (b)(6) 2021.

• Brand Name: BARDEX I.C. FOLEY CATHETER
• Common Device Name: FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 12003129
• Report Number: 1018233-2021-03537
• Device Sequence Number: 3589542
• Product Code: MJC
• UDI-Device Identifier: 00801741016790
• UDI-Public: (01)00801741016790
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K910318
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/04/2021

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 Model Number: 0165SI24
• Device Catalogue Number: 0165SI24
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/21/2021
• Supplement Date Received by Manufacturer: 08/04/2021
• Initial Report FDA Received Date: 06/15/2021
• Supplement Report FDA Received Date: 08/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other