MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARDEX LUBRI-SIL I.C. ALL-SILICONE FOLEY CATHETER; LUBRISIL IC 2WAY 5CC 16FR

Model Number 1758SI16

Device Problem Fluid/Blood Leak (1250)

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

Event Date 11/04/2020

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 foley was inserted for the first case and failed.Then a second foley was inserted and the balloon was filled with the fluid using a syringe to fill to 10ml.The syringe became disconnected, which caused half of the fluid was unable to fill.Then the foley was gently pulled until the resistance felt from the balloon.Also the urine leaked from an around foley site and foley fell out to floor with balloon completely deflated.The balloon was not pre-inflated as per the manufacturer's instructions.The balloon was tested and clearly had a hole on it.The patient had to be flipped back to a supine position and another catheter was inserted.

Event Description

It was reported that the foley was inserted for the first case and failed.Then a second foley was inserted and the balloon was filled with the fluid using a syringe to fill to 10ml.The syringe became disconnected, which caused half of the fluid was unable to fill.Then the foley was gently pulled until the resistance felt from the balloon.Also the urine leaked from an around foley site and foley fell out to floor with balloon completely deflated.The balloon was not pre-inflated as per the manufacturer's instructions.The balloon was tested and clearly had a hole on it.The patient had to be flipped back to a supine position and another catheter was inserted.

Manufacturer Narrative

Bd has determined that this mdr was reported in error as it was found to be a duplicate of an event previously reported.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.

• Brand Name: BARDEX LUBRI-SIL I.C. ALL-SILICONE FOLEY CATHETER
• Type of Device: LUBRISIL IC 2WAY 5CC 16FR
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 10934856
• MDR Text Key: 219163848
• Report Number: 1018233-2020-21280
• Device Sequence Number: 1
• Product Code: EZL
• UDI-Device Identifier: 00801741025228
• UDI-Public: (01)00801741025228
• Combination Product (y/n): N
• PMA/PMN Number: K040504
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 03/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1758SI16
• Device Catalogue Number: 1758SI16
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2020
• Date Manufacturer Received: 02/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other