MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARDEX® LUBRI-SIL® I.C. ALL-SILICONE FOLEY CATHETER; LUBRISIL IC 2-WAY CATHETER

Model Number 1758SI16

Device Problems Fluid/Blood Leak (1250); Device Operates Differently Than Expected (2913)

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 urine leaked from around the meatus of the patient while using the catheter.

Manufacturer Narrative

The reported issue (it was reported that urine leaked from around the meatus of the patient while using the catheter) was unconfirmed due to the product meets specification.No obvious defects were observed on the sample received.Per functional evaluation, the balloon was inflated with 10cc of tap water mixed with blue methylene and no leakage was found.The catheter balloon was deflated by itself and the 10cc of water were recovered.Then water was injected for the drainage lumen and no leakage was found.Per dimensional evaluation the balloon symmetry was found within specification.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: ¿recommended inflation capacities 5cc balloon: use 10ml sterile water, 30cc balloon: use 35ml sterile water, do not exceed recommended capacities.Visually inspect the product for any imperfections or surface deterioration prior to use." (b)(4).

Event Description

It was reported that urine leaked from around the meatus of the patient while using the catheter.

• Brand Name: BARDEX® LUBRI-SIL® I.C. ALL-SILICONE FOLEY CATHETER
• Type of Device: LUBRISIL IC 2-WAY 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: 7295030
• MDR Text Key: 101025324
• Report Number: 1018233-2018-00535
• Device Sequence Number: 1
• Product Code: EZL
• UDI-Device Identifier: 00801741025228
• UDI-Public: (01)00801741025228
• 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: 03/16/2018

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: Lay User/Patient
• Device Expiration Date: 03/24/2022
• Device Model Number: 1758SI16
• Device Catalogue Number: 1758SI16
• Device Lot Number: NGBQ1150
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/31/2018
• Initial Date FDA Received: 02/24/2018
• Supplement Dates Manufacturer Received: 03/15/2018
• Supplement Dates FDA Received: 03/16/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/25/2017
• 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