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

Catalog Number 1758SI18

Device Problem Material Split, Cut or Torn (4008)

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

Event Date 12/16/2023

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.

Event Description

It was reported that the foley catheter was removed on december 11th, probably because the tube was cut.They confirmed that the catheter was disconnected.They cut the inlet tube and discarded the bag.

Manufacturer Narrative

The reported event is confirmed cause unknown.Visual evaluation noted received 1 silicone foley catheter with sample port connector.Catheter was cut at the base of the bifurcation site and separated into two separate pieces.No additional cuts present on sample received.Also received 2 photo samples.Also received 3 photo samples.First photo sample shows top view of catheter showing catheter separated into two separate pieces.Second photo samples zoom in on point of breakage between both pieces.Third photo sample shows a portion of the product labelling with notes indicated by user in native language.Based on physical and photo sample received product does not meet specifications which states "catheter length must conform to drawing." although an exact root cause could not be determined a potential root cause could be inappropriate package design.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] 1.Method for use (1) do not inflate the balloon in the urethra.[the urethra may be injured.] (2) do not pull the catheter hard.[the bladder/urethra may be injured.] 2.Applicable patients ·patients with delirium who might pull out catheter [when patient tugs at catheter unconsciously, the bladder and urethra may be damaged.] [contraindications] 1.Method for use: (1) do not reuse.(2) do not resterilize.(3) this device contains 10% povidone-iodine.For patients with past history of allergic hypersensitivity to povidone-iodine or iodine, consider using alternative disinfectants.(4) 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.] (5) 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.] 2.Applicable patients patients with known allergy to silver coated catheter [shape, configuration and principles] bard® silver lubri-sil® foley tray consists of a balloon catheter, urine-collecting bag for closed drainage system, syringe prefilled with sterile water, water-soluble lubricant, antiseptic solution, tweezers, waterproof sheet, gauze pads, cotton balls, vinyl gloves and statlock foley.Some catheter types of the device may have a temperature sensor for measuring patient¿s core body temperature and there are several types of closed drainage bags.The bag and statlock foley included in the tray will depend on the product.The surfaces of the catheter are coated with a minute amount of metallic silver and further coated with polyurethane, having antiproliferative effects on microorganisms on the catheter. balloon catheter: silicone; silver coating this product is made with bacti-guard®* silver alloy coating. available in sizes 12 to 22 every 2fr 1.Balloon catheter foley catheter temperature-sensing catheter 2.Accessories closed drainage bag (the illustration shows one example of typical configurations.) [precautions] 1.Precautions for use (exercise caution when using the device in the following patients) 1) exercise caution when using the device in patients with high urinary calcium levels as encrustation on the balloon surface, catheter occlusion or damage may occur.2.Important precautions 1) when catheter is inadvertently removed, inspect the balloon and shaft of catheter for rupture, defect, etc.Before inserting a new catheter.2) when any part of the balloon and/or the catheter is missing, consider removing them using a cystoscope.3) when it is difficult to remove catheter by deflating the balloon, take appropriate measures according to the section ¿troubleshooting¿.3.Malfunction and adverse events 1) 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 failure to measure temperature improper temperature indication 2) 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 [storage method and expiration date] 1.Storage store in a dry, cool place away from heat, moisture, and direct sunlight.2.Expiration date indicated on the direct package and the outer box." 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 foley catheter was removed on december 11th, probably because the tube was cut.They confirmed that the catheter was disconnected.They cut the inlet tube and discarded the bag.

• 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: 18452751
• MDR Text Key: 332731075
• Report Number: 1018233-2023-09497
• Device Sequence Number: 1
• Product Code: EZL
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K040504
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/23/2024

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: 1758SI18
• Device Lot Number: NGGX5106
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/27/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/21/2023
• Initial Date FDA Received: 01/05/2024
• Supplement Dates Manufacturer Received: 05/23/2024
• Supplement Dates FDA Received: 05/28/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/05/2022
• 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