MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARDEX® LUBRI-SIL® ALL-SILICONE FOLEY CATHETER

Catalog Number 175814

Device Problems Partial Blockage (1065); Complete Blockage (1094)

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

Event Date 04/20/2022

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 patient had to leave some slack in the foley catheter to go from sitting, to standing and to laying down.It was also stated that the patient was having mobility problems as well as bladder problems, due to a neuromuscular disease.And stated that patient had a 500ml collection bag around the calf, during the day and 2 litre collection bag at night.Sometimes patient just use the valve and drain when full, however patient had prostatitis at the moment.It was also stated that sometimes the catheter kinks and blocks the drainage that was the joint between the catheter tube and the lumen as happened with the 14 inch.The 14inch was removed last week as it kept blocking with debris and clots as well.The patient currently had a 16 inch which was flowing much better, however that had now kinked approximately halfway between patient meatus and the catheter lumen.Once the catheter folds over like that it appears to develops a memory or weakness at that point, it then kept folding over at the same point as the catheter naturally moves around.The patient had tried different underwear loose fit boxers, trunks, boxer briefs, and briefs and none seem to have made much difference.As per the follow up information received via ibc on 25apr2022, it was stated that every time the 14-inch or 16-inch foley catheter kinked and the flow was completely blocked.This caused pain, bladder spasms and bypassing of the catheter.The patient noticed quite quickly during the day as they started to feel full and overnight the patient woke up with wet pyjamas and bleeding before feeling full.This was further complicated as shortly because after the 14-inch foley catheter was put in, it kept blocking with clot and debris.The patient was not sure when the blocking due to kink occurred.The patient made numerous requests for the 14-inch to be changed to 16-inch, but the district nurses refused to do it.The patient was sent to a&e.It was stated that the 16-inch catheter worked brilliantly until it kinked.If the patient wanted to change the size 16-inch catheter with the kink, they had to go to a&e again as it had not been in 12 weeks and was not totally blocked.The patient wanted to make sure that they were not doing anything wrong.The patient had a latex allergy, hence they needed a silicone catheter.The patient was treated for urinary tract infection with 7 days of nitrofuration and was 4 weeks into a 12-week course of ciprofloxacin for prostatitis.It was unknown whether those infections were due to the catheter blocking or just risks of an indwelling catheter.The 14-inch catheter was put into the patient on (b)(6) 2022.On (b)(6) 2022, the user noticed that 14-inch was kinking at the joint with lumen overnight.On (b)(6) 2022, the patient was tested positive for a urinary tract infection and treated with nitrofuration in a 7-day course.On (b)(6) 2022, the patient was diagnosed with prostatitis and started on a 12-week course of ciprofloxacin.On (b)(6) 2022, 14-inch catheter was changed due to bladder pain, blocking and clearing multiple times during the day and the night.It was stated that blocking and unblocking were caused by a mix of debris, clots and tube kinking.On (b)(6) 2022, 14-inch catheter was finally changed for 16-inch at a&e.The patient was more comfortable and there were no problems until 3 days later.On (b)(6) 2022 and (b)(6) 2022, the patient woke up overnight in pain and the bed was soaked from bypassing.The 16-inch catheter was totally blocked by kink.The user had wrapped 3m transpose waterproof surgical tape around the catheter over the kink.This successfully stopped blocking as long as the user checked the catheter position regularly.There were no problems with pain, clots or debris.It was stated that the patient would be more grateful, if there were any tips on caring for all silicone catheter, if they were differing from a latex or ptfe urethral catheter, indwelling catheter and foley catheter.The patient was familiar with indwelling catheters as they had needed them on and off for the past 30 years.The patient would prefer intermittent self-catheterization, but for the medical reasons, this was not always practical are possible.

Manufacturer Narrative

The reported event was inconclusive since there is no product sample to test.It is unknown whether the device had met relevant specifications.The product was not used for patient treatment or diagnosis.It was unknown whether the product had caused the reported failure.A potential root cause for this failure could be blocked by clots, etc.Visual evaluation of the attached photo sample noted one opened (without original packaging), used silicone foley catheter.Visual inspection of the attached photo sample noted a kink in the catheter.It was reported that the patient had a 500ml collection bag around the calf, during the day and 2-litre collection bag at night.Sometimes patient just use the valve and drain when full, however patient had prostatitis at the moment (pcn# d175816e).Also stated that sometimes the catheter kinks (pcn# d175814e) and blocks the drainage that was the joint between the catheter tube and the lumen as happened with the 14-inch.The 14inch was removed last week as it kept blocking with debris and clots as well (pcn# d175814e).Patient was currently had a 16-inch which was flowing much better, however that had now kinked approximately halfway between patient meatus and the catheter lumen (pcn# d175816e).The user noticed that 14-inch was kinking at the joint with lumen.(pcn# d175814e).Since the sample was not returned, the sample is unable to be tested to verify blockage.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: "warning: do not use ointments or lubricants having a petrolatum base.They will damage silicone.Visually inspect the product for any imperfections or surface deterioration prior to use.¿ use luer tip syringe to infl ate with stated ml of sterile water.Or ¿ for pre-fi lled products, remove clip and squeeze reservoir to infl ate with stated ml of sterile water.Storage: store catheters at room temperature away from direct exposure to light, preferably in the original box.For urological use only.To deflate catheter balloon: gently insert a 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 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.Female use only syringe of sterile water for balloon inflation.This is a single use device.Do not resterilize any portion of this device.Reuse and/or repackaging may create a risk of patient or user infection, compromise the structural integrity and/or essential material and design characteristics of the device, which may lead to device failure, and/or lead to injury, illness or death of the patient.Warning: after use, this product may be a potential biohazard.Handle and dispose of in accordance with accepted medical practice and applicable laws and regulations." the actual/suspected device was inspected.

Event Description

It was reported that the patient had to leave some slack in the foley catheter to go from sitting, to standing and to laying down.It was also stated that the patient was having mobility problems as well as bladder problems, due to a neuromuscular disease.And stated that patient had a 500ml collection bag around the calf, during the day and 2 litre collection bag at night.Sometimes patient just use the valve and drain when full, however patient had prostatitis at the moment.It was also stated that sometimes the catheter kinks and blocks the drainage that was the joint between the catheter tube and the lumen as happened with the 14 inch.The 14inch was removed last week as it kept blocking with debris and clots as well.The patient currently had a 16 inch which was flowing much better, however that had now kinked approximately halfway between patient meatus and the catheter lumen.Once the catheter folds over like that it appears to develops a memory or weakness at that point, it then kept folding over at the same point as the catheter naturally moves around.The patient had tried different underwear loose fit boxers, trunks, boxer briefs, and briefs and none seem to have made much difference.As per the follow up information received via ibc on 25apr2022, it was stated that every time the 14-inch or 16-inch foley catheter kinked and the flow was completely blocked.This caused pain, bladder spasms and bypassing of the catheter.The patient noticed quite quickly during the day as they started to feel full and overnight the patient woke up with wet pyjamas and bledding before feeling full.This was further complicated as shortly because after the 14-inch foley catheter was put in, it kept blocking with clot and debris.The patient was not sure when the blocking due to kink occurred.The patient made numerous requests for the 14-inch to be changed to 16-inch, but the district nurses refused to do it.The patient was sent to a&e.It was stated that the 16-inch catheter worked brilliantly until it kinked.If the patient wanted to change the size 16-inch catheter with the kink, they had to go to a&e again as it had not been in 12 weeks and was not totally blocked.The patient wanted to make sure that they were not doing anything wrong.The patient had a latex allergy, hence they needed a silicone catheter.The patient was treated for urinary tract infection with 7 days of nitrofuration and was 4 weeks into a 12-week course of ciprofloxacin for prostatitis.It was unknown whether those infections were due to the catheter blocking or just risks of an indwelling catheter.The 14-inch catheter was put into the patient on 23feb2022.On 14mar2022, the user noticed that 14-inch was kinking at the joint with lumen overnight.On 15mar2022, the patient was tested positive for a urinary tract infection and treated with nitrofuration in a 7-day course.On 29mar2022, the patient was diagnosed with prostatitis and started on a 12-week course of ciprofloxacin.On 06apr2022, 14-inch catheter was changed due to bladder pain, blocking and clearing multiple times during the day and the night.It was stated that blocking and unblocking were caused by a mix of debris, clots and tube kinking.On 13apr2022, 14-inch catheter was finally changed for 16-inch at a&e.The patient was more comfortable and there were no problems until 3 days later.On 16apr2022 and 17apr2022, the patient woke up overnight in pain and the bed was soaked from bypassing.The 16-inch catheter was totally blocked by kink.The user had wrapped 3m transpose waterproof surgical tape around the catheter over the kink.This successfully stopped blocking as long as the user checked the catheter position regularly.There were no problems with pain, clots or debris.It was stated that the patient would be more grateful, if there were any tips on caring for all silicone catheter, if they were differing from a latex or ptfe urethral catheter, indwelling catheter and foley catheter.The patient was familiar with indwelling catheters as they had needed them on and off for the past 30 years.The patient would prefer intermittent self-catheterization, but for the medical reasons, this was not always practical are possible.No medical intervention was reported for pain and bladder spasms.

• Brand Name: BARDEX® LUBRI-SIL® ALL-SILICONE FOLEY CATHETER
• Type of Device: 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: juan velez ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 14434687
• MDR Text Key: 292030705
• Report Number: 1018233-2022-03876
• Device Sequence Number: 1
• Product Code: EZL
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K984084
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/28/2022

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: Lay User/Patient
• Device Catalogue Number: 175814
• Device Lot Number: MYFW0023
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/26/2022
• Initial Date FDA Received: 05/19/2022
• Supplement Dates Manufacturer Received: 10/29/2022
• Supplement Dates FDA Received: 11/02/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/18/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other