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

Device Problem Difficult to Insert (1316)

Patient Problem Pain (1994)

Event Date 07/25/2022

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The information provided by bd represents all of the known information at this time.The device was not returned.

Event Description

It was reported that the patient had been self-catharized with a silicone foley catheter for the first time recently instead of a latex foley and it was more painful during insertion.Patient reported that the balloon on the catheter seemed to stick out farther on the silicone catheter than it did on the latex catheters.Informed the customer that they would need to use more lubrication than normally for silicone catheters as the material was more ridged.Also informed that there were different french sizes and it might benefit them to go down a fr size.No medical intervention was reported.Per follow up via phone on(b)(6)2022, stated that the intermittent catheters the patient previously used were simply too big for them.Patient had since ordered a new set of coated catheters and would be using a size 18 instead of a size 20.

Manufacturer Narrative

The reported event was inconclusive because no sample was returned.A potential root cause for this failure could be due to "tortuous anatomy (e.G.Enlarged prostate)".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 history record review could not be performed without a lot number.The product catalog number and the lot number for this device are unknown.Therefore, bd is unable to determine the associated labeling to review.The device was not returned.

Event Description

It was reported that the patient had been self-catharized with a silicone foley catheter for the first time recently instead of a latex foley and it was more painful during insertion.Patient reported that the balloon on the catheter seemed to stick out farther on the silicone catheter than it did on the latex catheters.Informed the customer that they would need to use more lubrication than normally for silicone catheters as the material was more ridged.Also informed that there were different french sizes and it might benefit them to go down a fr size.No medical intervention was reported.Per follow up via phone on 29jul2022, stated that the intermittent catheters the patient previously used were simply too big for them.Patient had since ordered a new set of coated catheters and would be using a size 18 instead of a size 20.

• Brand Name: ALL SILICONE 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: 15208888
• MDR Text Key: 305283853
• Report Number: 1018233-2022-06278
• Device Sequence Number: 1
• Product Code: EZL
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 10/21/2022

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: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/25/2022
• Initial Date FDA Received: 08/11/2022
• Supplement Dates Manufacturer Received: 10/22/2022
• Supplement Dates FDA Received: 10/31/2022
• 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