MAUDE Adverse Event Report: BARD SDN. BHD. -8040607 BARDIA ALL-SILICONE FOLEY CATHETER WITH 30CC RIBBED BALLOON 20 FR., STERILE

Catalog Number 806320

Device Problem Occlusion Within Device (1423)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/26/2016

Event Type  malfunction  

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 Description

It was reported that an occlusion was allegedly found in the irrigation lumen.

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 Description

It was reported that an occlusion was allegedly found in the irrigation lumen.

Manufacturer Narrative

Received only 3 way catheter.The reported event was unconfirmed, as the problem could not be reproduced.The evaluation found no blockage observed in drainage lumen.During the functional evaluation, inflated balloon with 10cc water and administered flow rate testing.While inflated, the flow rate was 580ml/min, 600ml/min and 590ml/min.The internal flow specification for a sample of this product type is 100ml/min minimum, so the sample met the internal flow rate specification.Water was introduced thru the drainage eye and came out from drainage funnel without difficulty.Unable to duplicate reported event.The catheter was dissected and no conditions found that could have contributed to the reported event.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use state the following: " when urinary flow cannot be noted, confirm that the catheter is neither occluded nor broken." (b)(4).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 Description

It was reported that an occlusion was allegedly found in the irrigation lumen.

• Brand Name: BARDIA ALL-SILICONE FOLEY CATHETER WITH 30CC RIBBED BALLOON 20 FR., STERILE
• Type of Device: FOLEY CATHETER
• Manufacturer (Section D): BARD SDN. BHD. -8040607; kulim industrial estate; lot 57c; kulim, kedah 09000 ; MY 09000
• Manufacturer (Section G): BARD SDN. BHD. -8040607; kulim industrial estate; lot 57c; kulim, kedah 09000 ; MY 09000
• Manufacturer Contact: amy gravley ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 6259629
• MDR Text Key: 65566009
• Report Number: 1018233-2017-00116
• Device Sequence Number: 1
• Product Code: EZL
• Combination Product (y/n): N
• PMA/PMN Number: K040504
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 04/03/2017

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
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2020
• Device Catalogue Number: 806320
• Device Lot Number: 5BK7049
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/27/2016
• Initial Date FDA Received: 01/18/2017
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 02/06/2017; 04/03/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/18/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1