MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARDEX® ALL-SILICONE FOLEY CATHETER; 2 WAY ALL SILICONE FOLEY CATHETER

Model Number	166816
Medical Device Problem Code	Material Invagination (1336)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	12/05/2018
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 catheter balloon deflated and was later found to be pulled beyond the meatus.The catheter was unable to be pushed back to re-inflate.There was no reported patient injury.
Additional Manufacturer Narrative
The device was not returned for evaluation.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: ¿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 fi ll 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." 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.The device was not returned.
Event or Problem Description
It was reported that the catheter balloon deflated and was later found to be pulled beyond the meatus.The catheter was unable to be pushed back to re-inflate.There was no reported patient injury.
Additional Manufacturer Narrative
The device was not returned for evaluation.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: ¿warning: do not use ointments or lubricants having a petrolatum base.They will damage silicone.English.Warning: after use, this product may be a potential biohazard.Handle and dispose of in accordance with accepted medical practice and applicable laws and regulations.Units 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.Visually inspect the product for any imperfections or surface deterioration prior to use.Use luer tip syringe to inflate with stated ml of sterile water.Or for pre-filled products, remove clip and squeeze reservoir to inflate with stated ml of sterile water.For urological use only.Do not use if package is damaged.Bard, bardex, bardia, biocath and lubricath are trademarks and/or registered trademarks of c.R.Bard, inc.Single use only.Do not resterilize consult instructions for use.C.R.Bard, inc.Covington, ga 30014 usa 1 800 526 4455 www.Bardmedical.Com.Manufacturer: 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.".
Event or Problem Description
It was reported that the catheter balloon deflated and was later found to be rolled and unable to be pulled beyond the meatus.The catheter was unable to be pushed back to re-inflate.There was no reported patient injury.
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.Corrections: date of report.
Event or Problem Description
It was reported that the catheter balloon deflated and was later found to be rolled and unable to be pulled beyond the meatus.The catheter was unable to be pushed back to re-inflate.There was no reported patient injury.

• Brand Name: BARDEX® ALL-SILICONE FOLEY CATHETER
• Common Device Name: 2 WAY ALL SILICONE FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8216721
• Report Number: 1018233-2019-00077
• Device Sequence Number: 10829286
• Product Code: GBM
• UDI-Device Identifier: 00801741029806
• UDI-Public: (01)00801741029806
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K760093
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 04/18/2019

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 Expiration Date: 04/01/2021
• Device Model Number: 166816
• Device Catalogue Number: 166816
• Device Lot Number: MYBYED08
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/11/2018
• Supplement Date Received by Manufacturer: 01/21/2019; 02/28/2019; 03/26/2019
• Initial Report FDA Received Date: 01/04/2019
• Supplement Report FDA Received Date: 01/24/2019; 03/13/2019; 04/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1