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

Catalog Number 165820

Device Problem Calcified (1077)

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

Event Date 07/06/2022

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The device was not returned.

Event Description

It was reported that the past three years had been a real struggle for the customer as the catheters had been giving a lot of hassle.At first, the patient used 16-inch size silicone catheters, which had always lasted them for 3 months, but recently the bulb inside the catheter started to deflate after around one month.Hence, the patient changed to bard 16-inch size hydrocath catheter which worked fine for a few months, then it begun to block after around a month.The patient changed it but the same thing occurred where they could not even flush it as it was so blocked.The urologist then moved the patient up to a bard 18-inch size catheter as the patient would get autonomic dysreflexia if it was blocked for a period of time, but it was still blocked.The urologist again moved the patient up to bard 20-inch size catheter which was still blocking and lasted only around a month and not for three months.The patient dissected the bard 20-inch silicone catheter that came out of them the other day and found that crystal like granules or stones about 3 cm long had blocked the catheter around the eyelet.Based on the urine sample, the doctor informed the patient that they got e-coli infection sensitive to macrodantin, so the patient was put on macrodantin 100mg 4 a day for 7 days, then after 7 days, 1 day for 6 months.It was also stated that the patient¿s urine always had a fishy smell when they empty the bag which would go away when the patient was on antibiotics and would come back after antibiotics got finished.The customer had been using the foley catheters for 20 years now and suprapubic catheter for 10 years.Per follow up information received via ibc on 18-jul-2022, it was stated that the bard 20-inch silicone catheter was removed from the patient to change it and it did not fall out.The e-coli infection appeared to have resulted from the use of bard silicon catheters and the patient experienced autonomic dysreflexia due to the blockage of size 18 silicone catheter.The customer provided material#226520 for 20-inch size in which they had blockage issues.It was unknown what medical intervention was provided for autonomic dysreflexia.

Manufacturer Narrative

The reported event was inconclusive because no sample was returned.A potential root cause for this failure could be ¿occlusion from biological materials¿.It is unknown whether the device had met relevant specifications.The product was used for treatment purposes.It was unknown whether the product had caused the reported failure.It is unknown whether the device had met relevant specifications.The product was used for treatment purposes.It was unknown whether the product had caused the reported failure.The device was not returned for evaluation.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: "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 inflate with stated ml of sterile water.Or ¿ for pre-filled products, remove clip and squeeze reservoir to inflate 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" the device was not returned.

Event Description

It was reported that the past three years had been a real struggle for the customer as the catheters had been giving a lot of hassle.At first, the patient used 16-inch size silicone catheters, which had always lasted them for 3 months, but recently the bulb inside the catheter started to deflate after around one month.Hence, the patient changed to bard 16-inch size hydrocath catheter which worked fine for a few months, then it begun to block after around a month.The patient changed it but the same thing occurred where they could not even flush it as it was so blocked.The urologist then moved the patient up to a bard 18-inch size catheter as the patient would get autonomic dysreflexia if it was blocked for a period of time, but it was still blocked.The urologist again moved the patient up to bard 20-inch size catheter which was still blocking and lasted only around a month and not for three months.The patient dissected the bard 20-inch silicone catheter that came out of them the other day and found that crystal like granules or stones about 3 cm long had blocked the catheter around the eyelet.Based on the urine sample, the doctor informed the patient that they got e-coli infection sensitive to macrodantin, so the patient was put on macrodantin 100mg 4 a day for 7 days, then after 7 days, 1 day for 6 months.It was also stated that the patient¿s urine always had a fishy smell when they empty the bag which would go away when the patient was on antibiotics and would come back after antibiotics got finished.The customer had been using the foley catheters for 20 years now and suprapubic catheter for 10 years.Per follow up information received via ibc on 18-jul-2022, it was stated that the bard 20-inch silicone catheter was removed from the patient to change it and it did not fall out.The e-coli infection appeared to have resulted from the use of bard silicon catheters and the patient experienced autonomic dysreflexia due to the blockage of size 18 silicone catheter.The customer provided material#226520 for 20-inch size in which they had blockage issues.It was unknown what medical intervention was provided for autonomic dysreflexia.

• Brand Name: BARDEX® 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: 15092892
• MDR Text Key: 302349722
• Report Number: 1018233-2022-05718
• Device Sequence Number: 1
• Product Code: EZL
• Combination Product (y/n): N
• Reporter Country Code: SF
• PMA/PMN Number: K040504
• 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: 10/12/2022

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: 165820
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/06/2022
• Initial Date FDA Received: 07/25/2022
• Supplement Dates Manufacturer Received: 10/13/2022
• Supplement Dates FDA Received: 10/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Other
• Patient Age: 40 YR
• Patient Sex: Male