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

Model Number 0165SI14

Device Problem No Flow (2991)

Patient Problem No Information (3190)

Event Date 07/19/2017

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 there was no urine flow from the catheter.The catheter was replaced.

Manufacturer Narrative

The device was not returned for evaluation.The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use state the following: "visually inspect the product for any imperfections or surface deterioration prior to use.If package is opened or if any imperfection or surface deterioration is observed, do not use.Using proper aseptic methods, remove catheter from package.Prepare patient per hospital/nursing recommended procedure.Proceed with catheterization using standard techniques.Inflate the balloon with sterile water to the volume stated on the inflation lumen of the catheter by using a water-filled luer tip syringe.Connect catheter to collection container.To deflate the balloon, gently reinsert the luer tip syringe into the valve and aspirate".(b)(4).The device was not returned.

Event Description

It was reported that there was no urine flow from the catheter.The catheter was replaced.

Event Description

It was reported that there was no urine flow from the catheter.The catheter was replaced.

Manufacturer Narrative

The reported event was unconfirmed.Received only a photo of the catheter for evaluation.Based on the photo received, no visual defects were observed.Functional testing was unable to be performed on the returned sample since no physical sample was returned.The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use state the following: "1.Visually inspect the product for any imperfections or surface deterioration prior to use.If package is opened or if any imperfection or surface deterioration is observed, do not use.2.Using proper aseptic methods, remove catheter from package.3.Prepare patient per hospital/nursing recommended procedure.4.Proceed with catheterization using standard techniques.5.Inflate the balloon with sterile water to the volume stated on the inflation lumen of the catheter by using a water-filled luer tip syringe.6.Connect catheter to collection container.7.To deflate the balloon, gently reinsert the luer tip syringe into the valve and aspirate [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) patients who are or have been allergic to natural rubber latex (2) patients with known allergy to silver coated catheter" (b)(4).

• Brand Name: BARDEX® I.C. 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: 6861528
• MDR Text Key: 86725981
• Report Number: 1018233-2017-04757
• Device Sequence Number: 1
• Product Code: MJC
• UDI-Device Identifier: 00801741016745
• UDI-Public: (01)00801741016745
• Combination Product (y/n): N
• PMA/PMN Number: K910318
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup,Followup
• Report Date: 02/12/2018

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 Model Number: 0165SI14
• Device Catalogue Number: 0165SI14
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2018
• Initial Date Manufacturer Received: 08/22/2017
• Initial Date FDA Received: 09/13/2017
• Supplement Dates Manufacturer Received: 12/21/2017; 02/11/2018
• Supplement Dates FDA Received: 12/27/2017; 02/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1