MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARDIA® FOLEY CATHETER SILICONE COATED; BARDIA CATHETER

Model Number 123514A

Device Problem Leak/Splash (1354)

Patient Problems Muscle Spasm(s) (1966); No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.

Event Description

It was reported that the catheter leaked.The patient advised that the leaking may be due to bladder spasms.The patient advised she will follow-up with her doctor.No medical intervention was reported.

Manufacturer Narrative

The reported event is inconclusive as no sample was returned for evaluation.A potential root cause for this failure mode could be bad fit with shaft/no drainage eye/ poorly seated balloon /bladder neck interface.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: "single patient use only.Do not reuse.Do not resterilize.For urological use only.Visually inspect the product for any imperfections or surface deterioation prior to use" correction: d10 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 catheter leaked.The patient advised that the leaking may be due to bladder spasms.The patient advised she will follow-up with her doctor.No medical intervention was reported.

• Brand Name: BARDIA® FOLEY CATHETER SILICONE COATED
• Type of Device: BARDIA CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8654472
• MDR Text Key: 146638727
• Report Number: 1018233-2019-02824
• Device Sequence Number: 1
• Product Code: EZC
• UDI-Device Identifier: 00801741095085
• UDI-Public: (01)00801741095085
• Combination Product (y/n): N
• PMA/PMN Number: K910846
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,distributor,other
• Type of Report: Initial,Followup
• Report Date: 07/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 123514A
• Device Catalogue Number: 123514A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1