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

Catalog Number 0165L14

Device Problem No Device Output (1435)

Patient Problem Incontinence (1928)

Event Date 12/01/2017

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The information provided by bard 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 bard.

Event Description

It was reported that the urine could not be drained through the catheter and then, urine leaked out of the urethra.

Event Description

It was reported that the urine could not be drained through the catheter and then, urine leaked out of the urethra.

Manufacturer Narrative

The reported issue was unconfirmed.The device was returned and visually inspected.Evaluation confirmed found no blockage observed in drainage lumen.Water was introduced through the drainage eye and came out from drainage funnel without difficulty.The sample was sent for a flow rate test and passed.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use states 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" (b)(4).

• 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: 7146632
• MDR Text Key: 95940121
• Report Number: 1018233-2017-06486
• 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: 02/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2021
• Device Catalogue Number: 0165L14
• Device Lot Number: 7GJ8066
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2017
• Date Manufacturer Received: 02/06/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1