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

Model Number 119316M

Device Problem Insufficient Information (3190)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/04/2020

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, while inserting the foley and went to instill the balloon port, the sterile water was leaking out side the tube at balloon and drainage port separately.Per follow-up via email on, it was reported that the foley was defective.Additional information required.

Manufacturer Narrative

The reported event could not be confirmed.A potential root cause was not chosen due to a lack of information.The lot number was unknown; therefore, the device history record could not be reviewed.Labeling review was not performed due to a lack of information.Correction: h.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, while inserting the foley and went to instill the balloon port, the sterile water was leaking out side the tube at balloon and drainage port separately.Per follow-up via email on, it was reported that the foley was defective.Additional information required.

• Brand Name: BARDEX LUBRI-SIL I.C. ALL-SILICONE TEMP SENSING FOLEY CATHETER
• Type of Device: SILICONE TEMP SENSING FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 11085792
• MDR Text Key: 226105714
• Report Number: 1018233-2020-22082
• Device Sequence Number: 1
• Product Code: MJC
• UDI-Device Identifier: 00801741039911
• UDI-Public: (01)00801741039911
• Combination Product (y/n): N
• PMA/PMN Number: K070582
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup
• Report Date: 06/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 119316M
• Device Catalogue Number: 119316M
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other