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

Catalog Number 123516A

Device Problems Break (1069); Disconnection (1171)

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

Event Date 02/18/2020

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 user found the inflation valve broken prior to use.

Event Description

It was reported that the user found the inflation valve broken prior to use.

Manufacturer Narrative

The reported even was confirmed, however the cause is unknown.Evaluation found that the inflation valve and cap were disconnected from the inflation valve.However, the valve and cap could be connected back to the inflation funnel manually and the catheter could be inflated and deflated without any difficulty.The exact cause o how and when the problem occurred could not be determined.A potential root cause for this failure mode could be funnel thickness incorrectly sized at build-up or finish dipping operations/ machine misalignment during valve/ cap assembly/ user related (rough handling or incorrect syringe used).The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: "[warnings] 1.Method for use (1)do not inflate the balloon in the urethra.[the urethra may be injured.] (2)do not pull the catheter hard.[the bladder/urethra may be injured.] 2.Applicable patients ·patients with delirium who might pull out catheter [when patient tugs at catheter unconsciously, the bladder and urethra may be damaged.] [directions for use] 1.Method of use 3) insert catheter into the urethral meatus and advance it until the balloon enters the bladder and urine flows out through the catheter.Using a syringe packaged in the tray, infuse specified volume of sterile water into the inflation lumen to inflate the balloon." 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.

• Brand Name: BARDIA® FOLEY CATHETER SILICONE COATED
• Type of Device: FOLEY CATHETER (LATEX)
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9844714
• MDR Text Key: 186110334
• Report Number: 1018233-2020-01873
• Device Sequence Number: 1
• Product Code: EZC
• Combination Product (y/n): N
• PMA/PMN Number: K910846
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Type of Report: Initial,Followup
• Report Date: 05/12/2020

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 Expiration Date: 05/28/2024
• Device Catalogue Number: 123516A
• Device Lot Number: 9KU024
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2020
• Initial Date Manufacturer Received: 02/25/2020
• Initial Date FDA Received: 03/17/2020
• Supplement Dates Manufacturer Received: 05/07/2020
• Supplement Dates FDA Received: 05/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1