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

Catalog Number 1758SI16

Device Problem Material Fragmentation (1261)

Patient Problems Urinary Retention (2119); Foreign Body In Patient (2687)

Event Date 12/16/2022

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 the lubri-silicone foley catheter tip broke off, after insertion, with the tip retained in the bladder.Per additional information received, via email on 19dec2022, a foley catheter was placed prior to orthopedic surgery.Went to move the catheter bag and the entire catheter slipped out with the tip missing.It was reported that the tip was cut off from the rest of catheter and can send sample if needed; attached pictures of broken tip.It was also stated that they called the urologist who advised to place another catheter and as long as there was no resistance or blood leave the foley catheter in until next morning.Foley catheter removed following morning patient with urinary retention and required another foley.Foley catheter in place and patient to see urologist this wednesday.

Manufacturer Narrative

The reported event is confirmed, and the cause is unknown.Visual evaluation noted 3 photo samples received all showing breakage of the catheter occurring at 3 different angles.Therefore, product does not meet specifications which states "there shall be smooth transition from the balloon to the shaft.The excess of ruggedness is prohibiting." although an exact root cause could not be determined a potential root cause could be incorrect material formulation.The product was used for patient diagnostic or treatment.The product was influenced by the reported event.A review of the dhr did not show any problems or conditions that would have contributed to the reported event.The instructions for use were found adequate and state the following: ¿warnings: on catheter, do not use ointments or lubricants having a petrolatum base.It may cause balloon to burst.After use, this product may be a potential biohazard.Handle and dispose of in accordance with accepted medical practice and applicable local, state, and federal laws and regulations.Users and/or patients within the european union, should report any serious incident that has occurred in relation to the device to the manufacturer and the competent authority of the member state in which the user and/ or patient is established.Users outside of the european union should report any serious incident that has occurred in relation to the device to the manufacturer and the regulatory authority of the country in which the user and/ or patient is established.Store catheters at room temperature and away from direct exposure to sunlight preferably in original packaging.Instructions for use: visually inspect the product for any imperfections or surface deterioration prior to use.If package is opened or if any imperfection or surface deterioration is observed, do not use.Follow your facility protocol for catheter stabilization and urine collection.Insertion 1.Wash hands.2.Use proper aseptic technique to prepare the patient for catheter insertion.3.Remove the catheter from wrap and lubricate the catheter.If hospital policy permits, it is possible to inject lubricant into the urethra.4.Catheterize the patient using dominant hand.5.When catheter tip has entered bladder, urine will flow through the catheter.A.For female, insert catheter 2 more inches (approximately 5 cm).B.For male, insert catheter all the way to bifurcation.6.Inflate the balloon with pre-filled water syringe if included.A.If pre-filled syringe is not included, then use a slip tip/luer lock syringe to fill catheter balloon with sterile water.Do not use needle.B.Do not exceed recommended capacities as stated on the inflation lumen of the catheter.7.Gently pull the catheter until the catheter balloon is snug against the bladder neck.Removal 1.Wash hands.2.Gently insert a luer slip tip syringe in the catheter valve.A.Never use more force than is required to make the syringe ¿stick¿ in the valve.3.Allow the pressure within the balloon to force the plunger back and fill the syringe.A.If you notice slow or no deflation, re-seat the syringe gently.4.Use only gentle aspiration to encourage deflation, if needed.Vigorous aspiration may collapse the inflation lumen, preventing balloon deflation.5.If balloon does not deflate, contact adequately trained professional for assistance, as directed by hospital protocol.6.After balloon is fully deflated, remove catheter, and dispose of in accordance with hospital policy.Note: aggressive traction, particularly in the presence of suturing, is not recommended for 100% silicone foley catheters.¿ 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 actual/suspected device was inspected.

Event Description

It was reported that the lubri-silicone foley catheter tip broke off after insertion, with the tip retained in the bladder.Per additional information received via email on 19dec2022, a foley catheter was placed prior to orthopedic surgery, went to move the catheter bag and the entire catheter slipped out with the tip missing, it was reported that the tip was cut off from the rest of catheter, and can send sample if needed, attached pictures of broken tip.It was also stated that they called the urologist who advised to place another catheter and as long as there was no resistance or blood, leave the foley catheter in until next morning.Foley catheter removed following morning, patient with urinary retention and required another foley.Foley catheter in place and patient to see urologist this wednesday.

• Brand Name: BARDEX® LUBRI-SIL® I.C. 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: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 16088203
• MDR Text Key: 307823876
• Report Number: 1018233-2022-10134
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2023
• Device Catalogue Number: 1758SI16
• Device Lot Number: NGCR0030
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/16/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/17/2018
• 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