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

Model Number 0165SI16

Device Problems Inflation Problem (1310); Failure to Infuse (2340); No Flow (2991)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 06/05/2018

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 water would not inject into the balloon, and the balloon could not be inflated after catheter placement.

Event Description

It was reported that water would not inject into the balloon, and the balloon could not be inflated after catheter placement.

Manufacturer Narrative

Received only catheter with smear on cap for evaluation.The evaluation found that the catheter could be inflated without difficulty.The catheter was dissected and found no conditions that would contribute to the reported problem.The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use states the following: "(6) insert catheter into 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 the specified volume of sterile water into the inflation lumen to inflate the balloon.".

• Brand Name: BARDEX® I.C. FOLEY CATHETER
• Type of Device: FOLEY CATHETER (LATEX)
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 7663614
• MDR Text Key: 113454871
• Report Number: 1018233-2018-02591
• Device Sequence Number: 1
• Product Code: MJC
• UDI-Device Identifier: 00801741016752
• UDI-Public: (01)00801741016752
• Combination Product (y/n): N
• PMA/PMN Number: K040658
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Type of Report: Initial,Followup
• Report Date: 07/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0165SI16
• Device Catalogue Number: 0165SI16
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2018
• Date Manufacturer Received: 07/17/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1