MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARDEX® LUBRICATH® FOLEY CATHETER CREEVY MODEL; IRRIGATION CATHETER

Model Number 01267522

Device Problems Partial Blockage (1065); Complete Blockage (1094); Inability to Irrigate (1337)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Date 02/04/2020

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 the irrigation way could not be used.Per additional information received via email on 13 feb 2020 from ibc representative, the irrigation funnel was occluded and the catheter could not be used to irrigate.

Manufacturer Narrative

The reported event was inconclusive as no sample was returned for evaluation.A potential root cause could be due to ¿no irrigation eye".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." 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 Description

It was reported that the irrigation way could not be used.Per additional information received via email on 13 feb 2020 from ibc representative, the irrigation funnel was occluded and the catheter could not be used to irrigate.

• Brand Name: BARDEX® LUBRICATH® FOLEY CATHETER CREEVY MODEL
• Type of Device: IRRIGATION CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9757322
• MDR Text Key: 184324149
• Report Number: 1018233-2020-01362
• Device Sequence Number: 1
• Product Code: EZC
• UDI-Device Identifier: 00801741018817
• UDI-Public: (01)00801741018817
• Combination Product (y/n): N
• PMA/PMN Number: K910195
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Type of Report: Initial,Followup
• Report Date: 03/29/2020

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 Model Number: 01267522
• Device Catalogue Number: 01267522
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/04/2020
• Initial Date FDA Received: 02/26/2020
• Supplement Dates Manufacturer Received: 03/23/2020
• Supplement Dates FDA Received: 04/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1