MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARDEX® LUBRI-SIL® ALL-SILICONE FOLEY CATHETER

Model Number 175816

Device Problems Material Invagination (1336); Material Deformation (2976)

Patient Problem Laceration(s) (1946)

Event Type  Injury  

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 nurse inflated the balloon with saline and gave a light tug to ensure it was stable.When she gave the light tug, the catheter came out, balloon still inserted.The balloon was not round like it normally is.All of the saline was on one side of the catheter tip and was shaped more like a semi-circle.The patient had to undergo an unplanned laceration repair, and her original orthopedic surgery was cancelled.

Manufacturer Narrative

The device was not returned for evaluation.The reported event was confirmed as use-related per the event description and labeling.The root cause was that the "user did not follow procedure".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." 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 that the nurse inflated the balloon with saline and gave a light tug to ensure it was stable.When she gave the light tug, the catheter came out, balloon still inserted.The balloon was not round like it normally is.All of the saline was on one side of the catheter tip and was shaped more like a semi-circle.The patient had to undergo an unplanned laceration repair, and her original orthopedic surgery was cancelled.

• Brand Name: BARDEX® LUBRI-SIL® ALL-SILICONE FOLEY CATHETER
• Type of Device: FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8949243
• MDR Text Key: 156090447
• Report Number: 1018233-2019-05232
• Device Sequence Number: 1
• Product Code: EZL
• UDI-Device Identifier: 00801741034169
• UDI-Public: (01)00801741034169
• Combination Product (y/n): N
• PMA/PMN Number: K040504
• 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: 09/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 175816
• Device Catalogue Number: 175816
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/06/2019
• Initial Date FDA Received: 08/30/2019
• Supplement Dates Manufacturer Received: 09/12/2019
• Supplement Dates FDA Received: 09/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention