MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARDEX LUBRICATH FOLEY CATHETER; FOLEY CATHETER (LATEX)

Catalog Number 0165L14

Device Problems Fluid/Blood Leak (1250); Decrease in Pressure (1490)

Patient Problem No Patient Involvement (2645)

Event Date 04/13/2020

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 water leaked from the balloon during a pretest.

Manufacturer Narrative

The reported event is unconfirmed.Evaluation found no leakage observed even when pressure was applied on sac.Sample undergone 7 days leak test and no leakage observed.The catheter was dissected and no conditions found that could have contributed to the reported event.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: "[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.(1) do not use in patients who are or have been allergic to natural rubber latex.[directions for use].(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.

Event Description

It was reported that the water leaked from the balloon during a pretest.

• Brand Name: BARDEX LUBRICATH FOLEY CATHETER
• Type of Device: FOLEY CATHETER (LATEX)
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 10028445
• MDR Text Key: 190316375
• Report Number: 1018233-2020-03047
• 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: distributor,other
• Type of Report: Initial,Followup
• Report Date: 07/15/2020

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: 11/28/2022
• Device Catalogue Number: 0165L14
• Device Lot Number: 9RD019
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2020
• Initial Date Manufacturer Received: 04/16/2020
• Initial Date FDA Received: 05/06/2020
• Supplement Dates Manufacturer Received: 06/24/2020
• Supplement Dates FDA Received: 07/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1