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

Model Number 33616

Device Problems Inflation Problem (1310); Failure to Infuse (2340)

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.The device was not returned.

Event Description

It was reported that the catheter balloon would not inflate.No medical intervention was reported.

Manufacturer Narrative

The reported event was inconclusive as no sample was returned for evaluation.A potential root cause could be due to a " kinked lumen".The lot number was unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: "warning: do not use ointments or lubricants having a petrolatum base.They will damage the catheter.Visually inspect the product for any imperfections or surface deterioration prior to use.Use luer tip syringe to inflate with stated ml of sterile water." the ifu also contains a recommended inflation capacity of "5cc balloon: use 10ml sterile water".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 the catheter balloon would not inflate.No medical intervention was reported.

• Brand Name: BARD SILASTIC FOLEY CATHETER
• Type of Device: SILASTIC FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 10095909
• MDR Text Key: 193418309
• Report Number: 1018233-2020-03478
• Device Sequence Number: 1
• Product Code: EZL
• UDI-Device Identifier: 00801741020063
• UDI-Public: (01)00801741020063
• Combination Product (y/n): N
• PMA/PMN Number: K951103
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,distributor,other
• Type of Report: Initial,Followup
• Report Date: 07/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 33616
• Device Catalogue Number: 33616
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1