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

Catalog Number 0165L16

Device Problems Disconnection (1171); Detachment of Device or Device Component (2907)

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

Event Date 04/01/2020

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 during the pretest, the inflation valve came off when the user attempted to extract the syringe.

Manufacturer Narrative

The reported event was confirmed.Evaluation found that the valve and cap were disconnected from the catheter.However, the catheter was not returned.The valve and cap were inspected and found no abnormalities that could contribute to the reported event.The exact cause of how and when the problem occurred could not be determined.The potential root cause for this failure mode could be due to operator error, user related (eg: rough handling of device) or defective valve and cap.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: "[directions for use].1.Method of use.The device is intended for single use only and is not reusable.(1) to secure a sterile field for the procedure, spread a clean wrapping paper.(2) place waterproof sheet beneath patient¿s buttocks.(3) put on sterile gloves.Open tray and place it on the wrapping paper.(4) cleanse the area around the external urethral meatus with the cotton balls immersed in the antiseptics.(5) lubricate the distal end of the catheter with water-soluble lubricant packaged in the tray.(6) 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 the specified volume of sterile water into the inflation lumen to inflate the balloon.".Correction: d4.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.

Event Description

It was reported that during the pretest, the inflation valve came off when the user attempted to extract the syringe.

• Brand Name: BARDEX LUBRICATH FOLEY CATHETER
• Type of Device: BARDIA FOLEY CATHETER (LATEX)
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9995149
• MDR Text Key: 189096024
• Report Number: 1018233-2020-02802
• 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: 07/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/28/2023
• Device Catalogue Number: 0165L16
• Device Lot Number: 9KZ034
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2020
• Date Manufacturer Received: 06/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1