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

Model Number 119314

Device Problems Partial Blockage (1065); Difficult to Remove (1528)

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

Event Date 04/18/2023

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 water was unable to removed from the foley catheter.The balloon was inflated during a pretest but the water was unable to removed even though it was inflated.

Manufacturer Narrative

The reported event was confirmed manufacturing related.One sample exhibited the reported failure.The device had not met specifications.The reported failure is considered out of specification as the reported failure was reproduced.The product was not used for patient treatment or diagnosis.The product caused the reported failure.Although a specific cause cannot be determined, based on the risk document s potential root cause for this event could be incorrect setup.Visual evaluation of the returned sample noted one opened (without original packaging), a 3-way temperature sensing catheter.Visual inspection noted that the balloon was inflated upon receival of sample.Attempted to deflate balloon passively using an in-house luer lock syringe and in-house straight tipped syringe.Only 1 ml could be withdrawn with both syringes and solution could not be withdrawn by aspiration.Replaced the returned inflation valve with an in-house inflation valve and retried deflation with both syringes.Neither syringe could withdraw solution passively nor by aspiration with the in-house valve.Dissected balloon and found that the notch was perforated completely.Dissected inflation funnel and none of the pin gauges could go through the inflation lumen.There was a block of extra silicon in the pathway.Two different pin gauges were inserted from different directions and both gauges hit "resistance" inside of the inflation lumen.This is out of specification which states, inspect for missing or incomplete funnel fill, poor gluing, damage or scratches.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.) 1.Method of use (1) cleanse the area around the external urethral meatus with the packaged cotton balls immersed in the antiseptics.(2) lubricate the catheter shaft with the lubricant jelly.(3) carefully insert the catheter into the urethral meatus.After the balloon advanced in the bladder, attach the needleless syringe, and gently infuse the specified volume of sterile water to inflate the balloon.(4) pull the catheter slightly to seat the balloon at the level of the bladder neck.(5) to deflate and remove the balloon, attach a needleless syringe to let sterile water in the balloon come out spontaneously through balloon deflation without aspiration.After balloon deflation, withdraw the catheter slowly while confirming that no abnormal resistance is encountered.2.Precautions for use (1) to secure a sterile field for the procedure, spread a clean wrapping paper.(2) place waterproof sheet beneath patient¿s buttocks.(fig.1) (3) put on sterile gloves.Open tray and place it on the wrapping paper.(fig.2) fig.1 fig.2 (4) cleanse the area around the external urethral meatus with the cotton balls immersed in the antiseptics.(fig.3) (5) lubricate the distal end of the catheter with water-soluble lubricant packaged in the tray.(fig.4) [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.H3 other text : the actual/suspected device was inspected.

Event Description

It was reported that water was unable to removed from the foley catheter.The balloon was inflated during a pretest but the water was unable to removed even though it was inflated.

• Brand Name: BARDEX® LUBRI-SIL® I.C. TEMPERATURE-SENSING 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: 16931509
• MDR Text Key: 315218681
• Report Number: 1018233-2023-03426
• Device Sequence Number: 1
• Product Code: MJC
• UDI-Device Identifier: 00801741039843
• UDI-Public: (01)00801741039843
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K070582
• 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: 06/08/2023

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
• Device Model Number: 119314
• Device Catalogue Number: 119314
• Device Lot Number: NGGS2167
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/25/2023
• Initial Date FDA Received: 05/15/2023
• Supplement Dates Manufacturer Received: 06/08/2023
• Supplement Dates FDA Received: 06/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/31/2022
• 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