MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 LUBRI-SIL® I.C. COMPLETE CARE® URINE METER FOLEY TRAY; URINE DRAINAGE BAG (CONOD)

Catalog Number 903114A

Device Problem No Flow (2991)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/08/2017

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 in the meter would not flow into the bag.The urine would flow out of the catheter into the meter successfully, but when the meter became filled, the urine would not flow into the bag.The user believed that there was an issue with the air filter.

Manufacturer Narrative

The reported issue was unconfirmed.The device was returned and visually inspected.Observed 3 needles were punctured on the urine meter air.Evaluation verified no abnormalities observed on the returned sample.Evaluation was conducted by introducing water into the urine meter to verify the flow rate of water out from the drainage bag.As result, the water was out smoothly without any restriction.Further, evaluation removed all the needles and sealed the air vent on the urine meter by using a clear tape prior to introducing water into the urine meter and drainage bag.Water was introduced again to verify the flow rate and water flowed out smoothly without any restriction.The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use state the following: (b)(4).

Event Description

It was reported that urine in the meter would not flow into the bag.The urine would flow out of the catheter into the meter successfully, however when the meter became filled, the urine would not flow into the bag.The user believed that there was an issue with the air filter.

• Brand Name: LUBRI-SIL® I.C. COMPLETE CARE® URINE METER FOLEY TRAY
• Type of Device: URINE DRAINAGE BAG (CONOD)
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 7161572
• MDR Text Key: 96473373
• Report Number: 1018233-2018-00017
• Device Sequence Number: 1
• Product Code: MJC
• Combination Product (y/n): N
• PMA/PMN Number: K984136
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Type of Report: Initial,Followup
• Report Date: 03/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 903114A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2018
• Date Manufacturer Received: 03/06/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1