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

Model Number 175814

Device Problems Inflation Problem (1310); Device Dislodged or Dislocated (2923); Material Deformation (2976)

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.

Event Description

It was reported that the after the foley catheter came out of the patient the balloon was only inflated on one side.The 10 cc of fluid was removed.The balloon was re-inflated multiple times and only inflated on one side.This was after a cesarean had been completed and the doctor had done a fundal massage.The catheter was replaced.Per additional information received via email from the complaint on 2-nov-18: the balloon was not pre-tested prior to insertion.

Manufacturer Narrative

The reported event was confirmed, however the cause could not be determined.Visual evaluation of the first photo of the sample noted one opened (no original packaging present), used foley catheter where the catheter balloon concentricity was observed to be 80:20.Visual evaluation of the last photo noted that the catheter was completely deflated and was currently being inflated with a syringe.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: ¿to deflate catheter balloon: gently insert a luer slip tip syringe in the catheter valve.Never use more force than is required to make the syringe ¿stick¿ in the valve.If you notice slow or no deflation, re-seat the syringe gently.Allow the balloon to deflate slowly on its own.Do not aspirate or manually accelerate the deflation of the balloon.If permitted by hospital protocol, the valve arm may be severed.If this fails, contact adequately trained professional for assistance, as directed by hospital protocol.Should balloon rupture occur, care should be taken to assure that all balloon fragments have been removed from the patient.Visually inspect the product for any imperfections or surface deterioration prior to use.".

Event Description

It was reported that the after the foley catheter came out of the patient the balloon was only inflated on one side.The 10 cc of fluid was removed.The balloon was re-inflated multiple times and only inflated on one side.This was after a cesarean had been completed and the doctor had done a fundal massage.The catheter was replaced.Per additional information received via email from the complaint on 02-nov-18: the balloon was not pre-tested prior to insertion.

• 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: 8078376
• MDR Text Key: 127547313
• Report Number: 1018233-2018-05457
• Device Sequence Number: 1
• Product Code: EZL
• UDI-Device Identifier: 00801741034152
• UDI-Public: (01)00801741034152
• Combination Product (y/n): N
• PMA/PMN Number: K984084
• 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: 01/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 175814
• Device Catalogue Number: 175814
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2018
• Date Manufacturer Received: 12/23/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 39 YR