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

Model Number 119108

Device Problem Decrease in Pressure (1490)

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

Event Date 12/02/2021

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 water leaked from the valve part of the foley catheter.It was stated that the device was not used on the patient.

Manufacturer Narrative

The reported event was confirmed however the cause was unknown.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.Visual evaluation of the returned used temp sensing catheter.Visual inspection of the sample noted no obvious visible defects.The catheter balloon was inflated with 3.5 ml methylene blue solution (3 drops 1% aq methylene blue per 100ml distilled water) and was allowed to rest with no observed leaks.Deflated with no issues or cuffing noted.Attempted to flush drainage funnel, and solution would not advance due to silicone blockage.This is out of specification per inspection procedure, which states, catheter leaks, valve leaks, balloon perforation, lumen to lumen, prematurely deflated and dislodged balloon are not allowed, and must inflate and deflate with the use of a syringe.The product was not used for patient treatment or diagnosis.The product caused the reported failure.A potential root cause for this failure could be excess silicone in mold.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 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 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 leased 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.) syringe prefilled with sterile water drainage tube bard ez-lok sampling port clip shaft shaft water soluble lubricant antiseptics: bard® 10% povidone-iodine solution tweezers gauze pads waterproof sheet cotton balls gloves statlock foley [intended use & effect- efficacy] the device combines a disposable catheter that is designed to be placed in the bladder for the purpose of urinary drainage and a urine drainage bag.[directions for use] 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.(3) put on sterile gloves.Open tray and place it on the wrapping paper.(4) cleanse the area around the external urethral meatus with the cotton balls immersed in the antiseptics.(5) lubricate the distal end of the catheter with water-soluble lubricant packaged in the tray.(6) insert catheter into the urethral meatus, and advance it until the balloon enters the bladder." h11:section a through f - the information provided by bd represents all of 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 water leaked from the valve part of foley catheter.The device was not used on the patient.Per sample evaluation from the investigator via email on 25may2022, it was reported that silicone blockage was found in the drainage lumen of the foley catheter.

• Brand Name: BARDEX® ALL-SILICONE TEMPERATURE-SENSING PEDIATRIC FOLEY CATHETER
• Type of Device: TEMPERATURE SENSING 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: 13119444
• MDR Text Key: 284529513
• Report Number: 1018233-2021-08565
• Device Sequence Number: 1
• Product Code: EZL
• UDI-Device Identifier: 00801741045998
• UDI-Public: (01)00801741045998
• 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: 07/25/2022

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 Model Number: 119108
• Device Catalogue Number: 119108
• Device Lot Number: NGEW0060
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/16/2021
• Initial Date FDA Received: 12/30/2021
• Supplement Dates Manufacturer Received: 07/26/2022
• Supplement Dates FDA Received: 07/27/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/13/2020
• 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