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

Model Number 175816

Device Problems Burst Container or Vessel (1074); Inflation Problem (1310); Improper or Incorrect Procedure or Method (2017); Device Handling Problem (3265)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/21/2020

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 foley catheter with a 5 ml balloon was overinflated in a patient's bladder and got burst.The fluid was supposed to go into the bladder during an operative procedure, but someone put it into the inflation lumen of the foley.As per the follow-up information received on 10 aug 2020,10 cc of saline was used to inflate the balloon.No intervention or harm to patient.No pieces of balloon were missing.

Manufacturer Narrative

The reported event was confirmed as use-related.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: "valve type: use luer slip tip syringe.Do not use needle.Recommended inflation capacities 3cc balloon: use 5cc sterile water 5cc balloon: use 10cc sterile water 30cc balloon: use 35cc sterile water do not exceed recommended capacities." 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 foley catheter with a 5 ml balloon was overinflated in a patient's bladder and got burst.The fluid was supposed to go into the bladder during an operative procedure, but someone put it into the inflation lumen of the foley.As per the follow-up information received on 10aug2020,10 cc of saline was used to inflate the balloon.No intervention or harm to patient.No pieces of balloon were missing.

• 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: 10430510
• MDR Text Key: 204347156
• Report Number: 1018233-2020-05293
• 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: distributor,other
• Type of Report: Initial,Followup
• Report Date: 11/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2020
• Is this an Adverse Event Report?: No
• 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
• Date Manufacturer Received: 11/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1