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

Catalog Number 0165L14

Device Problems Break (1069); Deflation Problem (1149); Device Fell (4014)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 09/04/2019

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 catheter fell out due to balloon damage a few hours after the placement.

Event Description

It was reported that the catheter fell out due to balloon damage a few hours after the placement.Per email received from the ibc representative on 17-oct-19, evaluation found balloon burst on returned sample.

Manufacturer Narrative

The reported event was confirmed, however, the cause is unknown.Evaluation of the device noted an irregular balloon burst.No pieces of the sac were missing.The sample was evaluated under a microscope and no conditions were found that could be associated with the reported event.The exact cause could not be determined.A potential root cause for this failure mode could be user related (example: contact with sharp object)/ / exposure to petrolatum based products mechanical failure/operator error.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." correction: d4.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.

• Brand Name: BARDEX® LUBRICATH® FOLEY CATHETER
• Type of Device: FLEY CATHETER (LATEX)
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9145193
• MDR Text Key: 182528011
• Report Number: 1018233-2019-06142
• 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: 10/29/2019

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: 04/02/2023
• Device Catalogue Number: 0165L14
• Device Lot Number: 9AH014
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2019
• Initial Date Manufacturer Received: 09/09/2019
• Initial Date FDA Received: 10/02/2019
• Supplement Dates Manufacturer Received: 10/23/2019
• Supplement Dates FDA Received: 10/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1