MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 VERTUS FOLEY

Model Number 0165B16

Device Problems Inflation Problem (1310); Difficult to Insert (1316)

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

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 evaluator stated that they were unsure if the catheter was comfortable for the patient, as the catheter was too flexible.They felt as though they had to cram it into the urethra.It was difficult to inflate the device.The device would not inflate and stay in place.The hospital was able to put a small amount of water into the catheter from the syringe prior to inflation.Troubleshooting was performed and the catheter was repositioned.The catheter did not meet any resistance internally.The patient had an epidural and there was no occlusion upon removal.

Manufacturer Narrative

The device was not returned for evaluation.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: ¿visually inspect the product for any imperfections or surface deterioration prior to use.If package is opened or if any imperfections of surface deterioration is observed, do not use." 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 by the evaluator that, they were unsure if the catheter was comfortable for the patient, as the catheter was too flexible.They felt as though they had to cram it into the urethra.It was difficult to inflate the device.The device would not inflate and stay in place.The hospital was able to put a small amount of water into the catheter from the syringe prior to inflation.Troubleshooting was performed and the catheter was repositioned.The catheter did not meet any resistance internally.The patient had an epidural and there was no occlusion upon removal.

• Brand Name: VERTUS FOLEY
• Type of Device: VERTUS FOLEY
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9711776
• MDR Text Key: 183354204
• Report Number: 1018233-2020-01051
• Device Sequence Number: 1
• Product Code: EZL
• UDI-Device Identifier: 00801741099212
• UDI-Public: (01)00801741099212
• Combination Product (y/n): N
• PMA/PMN Number: K180781
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 03/27/2020

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: Lay User/Patient
• Device Model Number: 0165B16
• Device Catalogue Number: 0165B16
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/23/2020
• Initial Date FDA Received: 02/14/2020
• Supplement Dates Manufacturer Received: 03/25/2020
• Supplement Dates FDA Received: 03/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1