MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD® FOLEY TRAY WITH BARD HYDROPHILIC-COATED FOLEY CATHETER; PRE CONNECTED CATHETER

Catalog Number 898314

Device Problems Deflation Problem (1149); Fluid/Blood Leak (1250); Detachment of Device or Device Component (2907)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 12/21/2018

Event Type  malfunction  

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 Description

It was reported that there was leakage.Additional information was received via email on (b)(6) 2019, from the (b)(4) representative, that the balloon of the catheter fell out and caused leakage.

Event Description

It was reported that there was leakage.Additional information was received via email on (b)(6)2019 , from the ibc representative, that the balloon of the catheter fell out and caused leakage.

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: ¿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 clips and squeeze reservoir to inflate with stated ml of sterile water".

• Brand Name: BARD® FOLEY TRAY WITH BARD HYDROPHILIC-COATED FOLEY CATHETER
• Type of Device: PRE CONNECTED CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8226511
• MDR Text Key: 132501411
• Report Number: 1018233-2019-00141
• Device Sequence Number: 1
• Product Code: EZC
• Combination Product (y/n): N
• PMA/PMN Number: K910846
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup
• Report Date: 03/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2021
• Device Catalogue Number: 898314
• Device Lot Number: NGBY2233
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1