MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD® URINE METER FOLEY CATHETER TRAY WITH BARDEX® ALL-SILICONE CATHETER; SILICONE FOLEY

Model Number	902416
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Codes	Muscle Spasm(s) (1966); Pain (1994)
Date of Event	08/08/2019
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.
Event or Problem Description
It was reported that the hospital has been noticing a leaking issue a lot more in the last 6-months to a year.Most of the new kidney transplants have had this issue, especially with the male patients.Foleys were leaking around the insertion site and the patients had reported more bladder spasms and pain.They have tried multiple things like switching out the foley's, or deflating the balloon and adding more fluid in the balloon but they continued to leak.Per email from customer on 13-sep-2019, there was not an exact number available.
Additional 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 were found adequate and state the following: ¿sterile unless package is opened or damaged, except for any individually packaged components within the tray which are not labeled as sterile.These components are not terminally sterilized.Caution: federal (u.S.A.) law restricts this device to sale by or on the order of a physician.Single use only.Do not resterilize.For urological use only.Warning: on catheter, do not use ointments or lubricants having a petrolatum base.They will damage the catheter and may cause balloon to burst.Warning: after use, this product may be a potential biohazard.Handle and dispose of in accordance with accepted medical practices and applicable local, state and federal laws and regulations.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.Please consult product label and insert for any indications, contraindications, hazards, warnings, cautions and directions for use.1.To deflate catheter balloon: gently insert a luer lock or slip tip syringe in the catheter valve.Never use more force than is required to make the syringe ¿stick¿ in the valve 2.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 3.Use only gentle aspiration to encourage deflation if needed.Vigorous aspiration may collapse the inflation lumen, preventing balloon deflation 4.If the balloon will not deflate and if permitted by hospital protocol, the valve arm may be severed.If this fails, contact adequately trained professional for assistance, as directed by hospital protocol 5.Should balloon rupture occur, care should be taken to assure that all balloon fragments have been removed from the patient" corrections: d4, d10 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.H3 other text : the device was not returned.
Event or Problem Description
It was reported that the hospital has been noticing a leaking issue a lot more in the last 6-months to a year.Most of the new kidney transplants have had this issue, especially with the male patients.Foleys were leaking around the insertion site and the patient's had reported more bladder spasms and pain.They have tried multiple things like switching out the foley's, or deflating the balloon and adding more fluid in the balloon but they continued to leak.Per email from customer on (b)(6) 2019, there was not an exact number available.

• Brand Name: BARD® URINE METER FOLEY CATHETER TRAY WITH BARDEX® ALL-SILICONE CATHETER
• Common Device Name: SILICONE FOLEY
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9145435
• Report Number: 1018233-2019-06148
• Device Sequence Number: 2158127
• Product Code: EZL
• UDI-Device Identifier: 00801741025068
• UDI-Public: (01)00801741025068
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K040504
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/15/2019

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
• Operator of Device: Health Professional
• Device Model Number: 902416
• Device Catalogue Number: 902416
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/12/2019
• Supplement Date Received by Manufacturer: 10/09/2019
• Initial Report FDA Received Date: 10/02/2019
• Supplement Report FDA Received Date: 10/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1