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

Model Number 165812

Device Problems Fluid/Blood Leak (1250); Material Puncture/Hole (1504); Material Split, Cut or Torn (4008)

Patient Problems Patient Problem/Medical Problem (2688); No Code Available (3191)

Event Date 06/02/2020

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 a foley catheter was placed in a child and once placed, it allegedly started leaking and was not effective.Supposedly, there was a visible hole in the tube distal to the bag connector area (from the y).Patient required additional ketamine for a new catheter to be inserted.

Event Description

It was reported that a foley catheter was placed in a child and once placed, it allegedly started leaking and was not effective.Supposedly, there was a visible hole in the tube distal to the bag connector area (from the y).Patient required additional ketamine for a new catheter to be inserted.As per additional information received via email on 12aug2020 from ibc representative, urine leaked from the hole.

Manufacturer Narrative

The reported event was inconclusive as no sample was returned for evaluation.A potential root cause for this failure could be, "inappropriate material handling (silicone catheters)." 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: "to deflate catheter balloon: gently insert a 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." 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.

• Brand Name: BARDEX 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: 10380111
• MDR Text Key: 202076021
• Report Number: 1018233-2020-05051
• Device Sequence Number: 1
• Product Code: EZL
• UDI-Device Identifier: 00801741029738
• UDI-Public: (01)00801741029738
• 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: 11/12/2020

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: 165812
• Device Catalogue Number: 165812
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/17/2020
• Initial Date FDA Received: 08/07/2020
• Supplement Dates Manufacturer Received: 10/23/2020
• Supplement Dates FDA Received: 11/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention