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

Device Problem Material Protrusion/Extrusion (2979)

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

Event Date 05/31/2023

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.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.H3 other text : the device was not returned.

Event Description

It was reported that foley catheter has an elevation at the balloon.This makes it near impossible to place as a suprapubic catheter.This means that they were having to use a smaller diameter catheter, i.E., 14fr, to maintain the tract of the suprapubic catheter.These work to hold the tract open but decreases efficacy of draining.This leaves the patient more prone to obstructions.Customer asked was there any other alternatives for 16fr straight catheters that they can use.Per follow up via mail received on 12jun2023, the issues customer had been with the non-latex catheters.On (b)(6) 2023 patient who had a 16fr suprapubic catheter since 12/21 was unable to have 16fr replaced, had to downsize to 14fr.On (b)(6) 2023 patient began with unc urology (b)(6) 2022 with spt in place.Attempted to place 18fr catheter (same size since 10/22), unsuccessfully.Unable to place 16fr, provider paged.By the time of provider's arrival, no spt could be placed.Patient had to go through interventional radiology to have spt reestablished.There were two more, but after our internal reports were placed, the exact information was forgotten.The problem was the ridge on the catheter balloon.It did not easily pass into the bladder.The other issue with have with all of the bd catheters was the cost.There was only one option that was latex free.This option was 2-3 times the cost of previous catheters used.

Event Description

It was reported that foley catheter has an elevation at the balloon.This makes it near impossible to place as a suprapubic catheter.This means that they were having to use a smaller diameter catheter, i.E., 14fr, to maintain the tract of the suprapubic catheter.These work to hold the tract open but decreases efficacy of draining.This leaves the patient more prone to obstructions.Customer asked was there any other alternatives for 16fr straight catheters that they can use.As per follow up via mail received on 12jun2023, the issues customer had been with the non-latex catheters.On 5/26 patient who had a 16fr suprapubic catheter since 12/21 was unable to have 16fr replaced, had to downsize to 14fr.On 5/19 patient began with unc urology 10/21/22 with spt in place.Attempted to place 18fr catheter (same size since 10/22), unsuccessfully.Unable to place 16fr, provider paged.By the time of provider's arrival, no spt could be placed.Patient had to go through interventional radiology to have spt reestablished.There were two more, but after our internal reports were placed, the exact information was forgotten.The problem was the ridge on the catheter balloon.It did not easily pass into the bladder.The other issue with have with all of the bd catheters was the cost.There was only one option that was latex free.This option was 2-3 times the cost of previous catheters used.

Manufacturer Narrative

The reported event was inconclusive because no sample was returned.A potential root cause for this failure could be due to "incorrect balloon design (balloon wall thickness excessive)".The dhr 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.Correction- d, g.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.H3 other text : the device was not returned.

• 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: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 17217303
• MDR Text Key: 318208332
• Report Number: 1018233-2023-04766
• 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,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/10/2023

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: 06/12/2023
• Initial Date FDA Received: 06/28/2023
• Supplement Dates Manufacturer Received: 10/05/2023
• Supplement Dates FDA Received: 10/11/2023
• 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