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

Catalog Number 909116M

Device Problem Gel Leak (1267)

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

Event Date 01/06/2021

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 povidone iodine was found to leak when the package was opened.

Event Description

It was reported that the povidone iodine was found to leak upon opening the package.

Manufacturer Narrative

The reported event was confirmed as a supplier related issue.The reported failure was able to be reproduced.The product was used for urological care.Based on the evaluation it was observed that the povidone iodine solution was leaked.The povidone iodine was inspected and observed a void channel which caused the leakage.A potential root cause for this failure mode could be due to a defective component or defect generated at suppliers site or during transit to bard.The lot number was unknown therefore the device history record could not be reviewed.The instructions for use were found adequate and state the following: "[directions for use] 1.Method of use the device is intended for single use only and is not reusable.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." 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 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: 11229154
• MDR Text Key: 228856579
• Report Number: 1018233-2021-00118
• 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: 05/10/2021

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 Catalogue Number: 909116M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2021
• Initial Date Manufacturer Received: 01/06/2021
• Initial Date FDA Received: 01/26/2021
• Supplement Dates Manufacturer Received: 05/10/2021
• Supplement Dates FDA Received: 06/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other