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

Model Number	0166V30S
Medical Device Problem Code	Failure to Infuse (2340)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
It was reported that when the balloon of the foley catheter was inflated, water filled the area just before the bifurcation on the catheter with minimal fluid being installed into the actual balloon.When attempting to deflate the balloon by attaching an empty syringe, the fluid would allegedly not drain completely from the balloon.
Event or Problem Description
It was reported that when the balloon of the foley catheter was inflated, water filled the area just before the bifurcation on the catheter with minimal fluid being installed into the actual balloon.When attempting to deflate the balloon by attaching an empty syringe, the fluid would allegedly not drain completely from the balloon.
Additional Manufacturer Narrative
The reported event was unconfirmed.The open and used balloon was inflated using a leur lock syringe to 30cc with no issues.The device was allowed to rest for one minute and no issues were observed.The device was deflated using the leur lock syringe without resistance.The two unopened lot samples were evaluated similarly with no issues observed.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: "inflation/deflation guidelines for urological use only.Warning: do not use ointments or lubricants having a petrolatum base.They will damage the catheter.Visually inspect the product for any imperfections or surface deterioration prior to use.¿ 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.¿ do not use needle.¿ do not exceed recommended capacities.To deflate catheter balloon: gently insert a luer slip tip syringe in the catheter valve.Never use more force than is required to make the syringe ¿stick¿ in the valve.Allow the pressure within the balloon to force the plunger back and fill the syringe with water.If you notice slow or no deflation, re-seat the syringe gently.Use only gentle aspiration to encourage deflation if needed.Vigorous aspiration may collapse the inflation lumen, preventing balloon deflation.If necessary, contact adequately trained professional for assistance, as directed by hospital protocol.Should balloon rupture occur, care should be taken to assure that all balloon fragments have been removed from the patient.This is a single use device.Do not resterilize any portion of this device.Reuse and/or repackaging may create a risk of patient or user infection, compromise the structural integrity and/or essential material and design characteristics of the device, which may lead to device failure, and/or lead to injury, illness or death of the patient.".

• Brand Name: BARDEX® SILICONE COATED FOLEY CATHETER
• Common Device Name: FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 7819379
• Report Number: 1018233-2018-03795
• Device Sequence Number: 14062021
• Product Code: KOD
• UDI-Device Identifier: 00801741039560
• UDI-Public: (01)00801741039560
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K922431
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/29/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2019
• Device Model Number: 0166V30S
• Device Catalogue Number: 0166V30S
• Device Lot Number: NGAY2945
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2018
• Initial Date Received by Manufacturer: 08/06/2018
• Supplement Date Received by Manufacturer: 11/16/2018
• Initial Report FDA Received Date: 08/27/2018
• Supplement Report FDA Received Date: 11/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 69 YR
• Patient Weight: 87