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

Catalog Number 1758SI16

Device Problems Decrease in Pressure (1490); Material Puncture/Hole (1504)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/26/2020

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 foley catheter fell out spontaneously.

Event Description

It was reported that the foley catheter fell out spontaneously.

Manufacturer Narrative

The reported event was confirmed however the cause was unknown.One sample was confirmed to exhibit the reported failure.Visual evaluation of the returned sample noted one opened (without original package) used silicone foley catheter was received.Visual inspection of the sample noted no obvious visible defects.The catheter balloon was inflated with 10 ml methylene blue solution (3 drops 1 percent aqueous methylene blue per 100 ml distilled water) and solution immediately leaked from a 0.018 inch pinhole in the balloon surface.There were no missing pieces observed.A potential root cause for this failure mode could be due to imperfection in balloon due to the process.The device did not meet the specifications.The product used for the treatment.The product had caused the reported failure.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 percent 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.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 and urine flows out through the catheter.Using a syringe packaged in the tray, infuse the specified volume of sterile water into the inflation lumen to inflate the balloon.7) pull catheter to seat the balloon at the level of the bladder neck and secure placement.8) keep the drainage bag below the bladder level without touching the floor.9) when catheter with temperature-sensing is used, connect lead wire to monitor with relay cable.10) secure drainage tube to bed sheet with clip to ensure that there is neither twist nor kink in the tube.11) to deflate balloon and remove catheter, insert a luer tip (needleless) syringe in the inflation valve to allow the water drain spontaneously.After balloon deflation, withdraw the catheter while confirming that no resistance is encountered." 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.

• 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
• MDR Report Key: 11012704
• MDR Text Key: 221797681
• Report Number: 1018233-2020-21696
• Device Sequence Number: 1
• Product Code: EZL
• Combination Product (y/n): N
• PMA/PMN Number: K040504
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 03/09/2021

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 Expiration Date: 11/28/2023
• Device Catalogue Number: 1758SI16
• Device Lot Number: NGCY1926
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2020
• Initial Date Manufacturer Received: 11/19/2020
• Initial Date FDA Received: 12/15/2020
• Supplement Dates Manufacturer Received: 03/09/2021
• Supplement Dates FDA Received: 04/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other