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

Model Number 0165SI24

Device Problems Partial Blockage (1065); Inaccurate Flow Rate (1249)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/29/2021

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.

Event Description

It was reported that the foley catheter was not draining about 2 weeks after being changed.The user had done few sleuthing like cutting the tip off and inflated balloon of the 2 week old catheter, where it showed the balloon material had occluded the inner lumen of the catheter and it was not draining.Per additional information received, at least 7 patients had similar issues, where 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.Some had the same issue and when they deflate the balloon or exchange the catheter, it drained.Most of the time patients were noticing the issue about 2-3 weeks after the exchange.Also stated that when a catheter was pulled out of a patient after about 2 weeks and re-inflated the balloon, it clearly showed the blocking in lumen of the catheter.Per follow up via email on 14apr2021, customer reported that they were having issues with 24 fr catheters with various lots.Each case happened at almost exactly 2 weeks after the catheter was inserted.

Manufacturer Narrative

The reported event was confirmed however the cause was unknown.The product had caused the reported failure.Based on evaluation finding, it was observed salt accumulation that causing drainage lumen occlusion which can cause flowrate issue.A potential root cause for this failure could be user related (example: over aspirated, incorrect syringe)/collapse lumen/sac close eye/valve damage/salt accumulation.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: "caution: this product contains natural rubber latex which may cause allergic reactions.To deflate catheter balloon: gently insert a luer slip 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 recommended inflation capacities 3cc balloon: use 5cc sterile water 5cc balloon: use 10cc sterile water 30cc balloon: use 35cc sterile water 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.Catheters should be replaced in accordance with the cdc guideline, "guideline for prevention of catheter-associated urinary tract infection." at the onset or first signs of a urinary tract infection, catheter encrustation, or any other catheter related adverse effect, the catheter should be replaced.Do not exceed recommended capacities.Sterile: unless package is opened or damaged.Do not use if package is opened or damaged.Single use only.Do not reuse.Do not resterilize.For urological use only.Valve type: use luer slip syringe.Do not use needle.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." corrections: d, h.H11: section a through f - the information provided by bard represents all of 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 bard.H3 other text : the actual/suspected device was inspected.

Event Description

It was reported that the foley catheter was not draining about 2 weeks after being changed.The user had done few sleuthing like cutting the tip off and inflated balloon of the 2-week-old catheter, where it showed the balloon material had occluded the inner lumen of the catheter and it was not draining.Per additional information received, at least 7 patients had similar issues, where 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.Some had the same issue and when they deflate the balloon or exchange the catheter, it drained.Most of the time patients were noticing the issue about 2-3 weeks after the exchange.It was also stated that when a catheter was pulled out of a patient after about 2 weeks and re-inflated the balloon, it clearly showed the blocking in lumen of the catheter.Per follow up via email on (b)(6) 2021, customer reported that they were having issues with 24 fr catheters 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.

• Brand Name: BARDEX I.C. FOLEY CATHETER
• Type of Device: FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 11697177
• MDR Text Key: 246521522
• Report Number: 1018233-2021-02236
• Device Sequence Number: 1
• Product Code: MJC
• UDI-Device Identifier: 00801741016790
• UDI-Public: (01)00801741016790
• Combination Product (y/n): N
• PMA/PMN Number: K910318
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 08/25/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 03/28/2023
• Device Model Number: 0165SI24
• Device Catalogue Number: 0165SI24
• Device Lot Number: MYES4345
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2021
• Initial Date Manufacturer Received: 03/29/2021
• Initial Date FDA Received: 04/20/2021
• Supplement Dates Manufacturer Received: 08/25/2021
• Supplement Dates FDA Received: 09/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other