MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARDEX LUBRICATH TEMPERATURE-SENSING URINE METER FOLEY TRAY

Catalog Number 909116M

Device Problem Tear, Rip or Hole in Device Packaging (2385)

Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/23/2020

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 it was confirmed the blue plastic bag of the package was torn when it was opened on the day of placement.

Manufacturer Narrative

The reported event was confirmed however the cause was unknown.The sample was evaluated and found there was a tear on the polysleeve of the catheter that contributed as per the reported event.However the exact cause on how and when the problem was occurred could not be determined.The reported failure was able to be reproduced.The product was used for urological care.A potential root cause for this failure mode could be due to operator error or user mishandling or storage condition or during transition to bard.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 or urethra may be injured.] 2.Applicable patients (1) 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: (1) do not use in patients who are or have been allergic to natural rubber latex.[directions for use] 1.Method of use the device is intended for single use only and is not reusable.(1) to secure a sterile field for the procedure, spread a clean wrapping paper.(2) place waterproof sheet beneath patients 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) secure drainage tube to bed sheet with clip to ensure that there is neither twist nor released kink in the tube.(10) 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.

Event Description

It was reported that the blue plastic bag of the package was torn when it was opened on the day of placement.

• Brand Name: BARDEX LUBRICATH TEMPERATURE-SENSING URINE METER FOLEY TRAY
• Type of Device: FOLEY TRAY
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 11008946
• MDR Text Key: 221497851
• Report Number: 1018233-2020-21683
• Device Sequence Number: 1
• Product Code: EZC
• Combination Product (y/n): N
• PMA/PMN Number: K910846
• 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: 04/29/2021

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: 08/28/2023
• Device Catalogue Number: 909116M
• Device Lot Number: MYEU2702
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2020
• Initial Date Manufacturer Received: 11/25/2020
• Initial Date FDA Received: 12/15/2020
• Supplement Dates Manufacturer Received: 04/29/2021
• Supplement Dates FDA Received: 05/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other