MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARDIA® COMPLETE FOLEY KIT

Model Number	800316
Medical Device Problem Code	Partial Blockage (1065)
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 device was not returned.
Event or Problem Description
It was reported that when attempting to inject water through the stuck valve, water passed through the valve.However, there seemed to be some type of blockage or lock around the syringe tip that did not allow a complete flow of the water.No medical intervention was reported.
Additional Manufacturer Narrative
The device was not returned for evaluation.A potential root cause for this failure could be "encrustation of eye from biological material deposits".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: ¿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.Inflate with 30ml sterile water wait at least 30 seconds for balloon deflation 1.Open csr wrap to form sterile field.2 place underpad beneath patient, plastic side down.3.Put on cuffed gloves.4.Open lubricant/lubricate catheter.5.Open povidone-iodine swabs.6.Prepare patient with swabs.7.Proceed with catheterization in usual manner.To inflate catheter, simply insert tip of water-filled syringe gently into valve (do not overpenetrate) and depress plunger.Instill entire amount of sterile water (30cc).8.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 permitted by hospital protocol, the valve arm may be severed.If this fails, 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.H3 other text : the device was not returned.
Event or Problem Description
It was reported that when attempting to inject water through the stuck valve, water passed through the valve.However, there seemed to be some type of blockage or lock around the syringe tip that did not allow a complete flow of the water.No medical intervention was reported.

• Brand Name: BARDIA® COMPLETE FOLEY KIT
• Common Device Name: COMPLETE FOLEY KIT
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8922932
• Report Number: 1018233-2019-05016
• Device Sequence Number: 2048517
• Product Code: KOD
• UDI-Device Identifier: 00801741040290
• UDI-Public: (01)00801741040290
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K922431
• 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): 08/27/2019

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: Lay User/Patient
• Device Model Number: 800316
• Device Catalogue Number: 800316
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/30/2019
• Supplement Date Received by Manufacturer: 08/23/2019
• Initial Report FDA Received Date: 08/22/2019
• Supplement Report FDA Received Date: 08/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1