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 Discomfort (2330); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 03/15/2024

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.

Event Description

It was reported that the 12 french and 14 french foley catheter tips were folded over themselves after the balloon was deflated.It left a large ridge in the tip of the foley catheter which caused resistance/trauma to the urethra on removal and added discomfort to the patients on removal.The event occurred when the balloons were inflated with 10 cc normal saline.The fold occurs on the majority of catheters when balloons are tested and not tested prior to insertion.Attempts to re inflate the balloon and then deflate the balloon prior to removal also do not get rid of the ridge.No medical intervention was reported.

Event Description

It was reported that the 12 french and 14 french foley catheter tips were folded over themselves after the balloon was deflated.It left a large ridge in the tip of the foley catheter which caused resistance/trauma to the urethra on removal and added discomfort to the patients on removal.The event occurred when the balloons were inflated with 10 cc normal saline.The fold occurs on the majority of catheters when balloons are tested and not tested prior to insertion.Attempts to re inflate the balloon and then deflate the balloon prior to removal also do not get rid of the ridge.No medical intervention was reported.As per the investigator notification, there were additional 3 samples with material # 165812 and batch number nghy2926.All of the three samples were used and the balloon part was mushroomed.

Manufacturer Narrative

The reported event is confirmed cause unknown.Photo: received six (6) photo samples.All photo samples showcase an overview of an all-silicone foley catheter and packaging.Visual: visual evaluation of the returned sample noted one opened (with original packaging), an all-silicone foley catheter.Visual inspection noted the balloon had mushroomed.This is out of specification, which states, " balloon must not cuff after deflation".Although a root cause could not be definitively identified, based on the risk documentation review, a potential root cause for this type of failure could be balloon material does not shrink quickly enough.However, there was insufficient information to confirm this potential root cause.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: "[warnings] method for use: when catheter is inadvertently removed, inspect the balloon and shaft of catheter for rupture, defect, etc.Before inserting a new catheter.[fragment of the balloon or segment of catheter may remain in the bladder.] do not pull the catheter hard.[the catheter including a balloon may be damaged or the bladder/urethral mucous membrane may be injured.] since it may be difficult to remove catheter even after balloon deflation in some cases, the catheter should be removed under the physician¿s instructions by reference to the section ¿troubleshooting¿.When deflating balloon, allow balloon to deflate on its own; do not aspirate with a syringe.[the inflation lumen for balloon deflation may be occluded by negative pressure, and as a result the balloon cannot be removed.] when inserting catheter with a stylet, confirm that the stylet has reached the tip of the catheter, and make sure to keep the stylet in place inside the catheter during insertion.[the stylet may exit the side hole to damage the urethral mucosa.] applicable patients: use with great care for patients with disturbance of consciousness, etc.[when patient removes catheter unconsciously, the mucosa of the bladder and urethra may be damaged, balloon may be ruptured, catheter may be broken, and catheter fragments may be left behind in the bladder.] [contraindications] method for use: do not reuse.Do not resterilize.Be careful that the catheter is not exposed to ointments, contrast medium or oil-based lubricants (including vegetable oils such as olive oil, mineral oils such as white petrolatum and animal oils).[they may damage the device and may burst balloon.] do not hold the device with forceps, etc.Avoid contact with any blades or sharp-edged instruments.[catheter damage may cause balloon rupture and accidental balloon removal or failure to deflate or remove the balloon.] no substance except sterile water should be used to inflate the balloon.[if contrast medium is used, balloon may burst.If normal saline is used, crystallized salt may occlude the inflation lumen to prevent deflation of the balloon.If air is used, air may escape to cause inadvertent deflation of the 3.Malfunction and adverse events.Malfunction: catheter kinking, damage, rupture.Difficulty or failure to remove the device.Occlusion of catheter inner lumens.Encrustation accidental removal of the device due to leakage of sterile water or balloon rupture device damage due to inappropriate use.Adverse events: urinary-tract infection.Hemorrhage, hematuria.Allergy reaction to the device.Calculus formation.Edema.Pain.Discomfort.Injury of bladder or urethral.Urethritis, urinary incontinence.Retained balloon fragments.Precautions for infection or contamination: visually inspect the product for any imperfections or surface deterioration prior to use.If package is opened or damaged or if any imperfection or surface deterioration is observed, do not use.Use this device immediately after opening the package.After use, handle and dispose of in accordance with accepted medical practice and applicable regulations.[storage method and expiration date] storage: store in a dry, cool place avoiding direct sunlight.Expiration date: indicated on the direct package and the outer box." correction: d.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 actual/suspected device was inspected.

• Brand Name: BARDEX® ALL-SILICONE FOLEY CATHETER
• Type of Device: SILICONE 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: 19040120
• MDR Text Key: 339330358
• Report Number: 1018233-2024-01843
• Device Sequence Number: 1
• Product Code: EZL
• UDI-Device Identifier: 00801741029738
• UDI-Public: (01)00801741029738
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 05/02/2024

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: NGHW0188
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/15/2024
• Initial Date FDA Received: 04/04/2024
• Supplement Dates Manufacturer Received: 05/02/2024
• Supplement Dates FDA Received: 05/03/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/11/2023
• 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