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

Model Number 175816

Device Problem Hole In Material (1293)

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

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 the catheter had tape on it; when the tape was removed from the catheter, it was noticed that there was a hole in the drainage funnel of the catheter.

Manufacturer Narrative

Received 1 used drainage bag with the catheter still attached.The reported issue was confirmed; however the cause was unknown.Per visual inspection, a damage/tear in an irregular form was observed approximately 0.125¿ from the bifurcation on the drainage lumen.Per functional evaluation, water was injected through the drainage lumen and leakage was noted from the damage/ tear below the bifurcation area on the drainage lumen.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: "visually inspect the product for any imperfections or surface deterioration prior to use".(b)(4).

Event Description

It was reported that the catheter had tape on it; when the tape was removed from the catheter, it was noticed that there was a hole in the drainage funnel of the catheter.

• Brand Name: BARDEX® LUBRI-SIL® ALL-SILICONE FOLEY CATHETER
• Type of Device: LUBRIS FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• Manufacturer (Section G): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• Manufacturer Contact: amy gravley ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 6692441
• MDR Text Key: 79506111
• Report Number: 1018233-2017-03498
• Device Sequence Number: 1
• Product Code: EZL
• UDI-Device Identifier: 00801741034169
• UDI-Public: (01)00801741034169(10)NGAX1211
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040504
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/05/2017

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: 10/13/2021
• Device Model Number: 175816
• Device Catalogue Number: 175816
• Device Lot Number: NGAX1211
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/16/2017
• Initial Date FDA Received: 07/07/2017
• Supplement Dates Manufacturer Received: 08/30/2017
• Supplement Dates FDA Received: 09/05/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/14/2016
• 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