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

Catalog Number 165812

Device Problem Material Invagination (1336)

Patient Problems Pain (1994); Tissue Breakdown (2681)

Event Date 05/20/2022

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 there were problems with pain in patients when the users pulled the foley catheters.It was stated that the balloon formed a ring which when pulled through the urethra was causing pain and possible injury to the patient.The balloon was filled with sterile water according to the instructions and the patient did not have urinary stones.It was also reported that the same form was observed after draining the balloon of an unused catheter.No medical intervention was reported.Per follow-up information received from ibc on (b)(6) 2022, stated that it was difficult to avoid that no patient injury had occurred during the use of the catheters as in that case it was the urethra that was damaged.When the catheters were to be pulled, the patients experienced high pain, which caused the staff to inspect the catheters.It was then seen that the bulging balloon on the catheters had formed a relatively strong ring around the catheter, which probably contributed to the pain.No sign of bleeding could be seen in any of the patients.

Event Description

It was reported that there were problems with pain in patients when the users pulled the foley catheters.It was stated that the balloon formed a ring which when pulled through the urethra was causing pain and possible injury to the patient.The balloon was filled with sterile water according to the instructions and the patient did not have urinary stones.It was also reported that the same form was observed after draining the balloon of an unused catheter.No medical intervention was reported.Per follow-up information received from ibc on 30may2022, stated that it was difficult to avoid that no patient injury had occurred during the use of the catheters as in that case it was the urethra that was damaged.When the catheters were to be pulled, the patients experienced high pain, which caused the staff to inspect the catheters.It was then seen that the bulging balloon on the catheters had formed a relatively strong ring around the catheter, which probably contributed to the pain.No sign of bleeding could be seen in any of the patients.

Manufacturer Narrative

The reported event was confirmed cause unknown.1 sample was confirmed to exhibit the reported failure.The device had not met specifications.Visual evaluation of the returned sample noted one opened (without original packaging), silicone foley catheter received with inflation valve and funnel cut off.Visual inspection of the sample noted balloon mushroom on the catheter.A potential root cause for this failure could be balloon material does not shrink quickly enough.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 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." the actual/suspected device was evaluated.

• 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: 14621845
• MDR Text Key: 293556092
• Report Number: 1018233-2022-04442
• Device Sequence Number: 1
• Product Code: EZL
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K040504
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/22/2022

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
• Device Catalogue Number: 165812
• Device Lot Number: MYFX4594
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/20/2022
• Initial Date FDA Received: 06/07/2022
• Supplement Dates Manufacturer Received: 09/23/2022
• Supplement Dates FDA Received: 09/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/26/2021
• 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): Other