MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD® SILASTIC® FOLEY CATHETER; SILASTIC FOLEY CATHETER

Catalog Number 33618

Device Problem Material Puncture/Hole (1504)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 03/08/2024

Event Type  Injury  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.H11: section a through f - the information provided by bd represents all 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 customer had been facing issues with the silastic foley catheters.They had 2 defective balloons in them.They both deflated and actually ended up having to go to an emergency.Both the catheters were from the same lot and there were 11 in total.As per the follow up information received on 13mar2024, the patient underwent a medical intervention in the emergency room.

Manufacturer Narrative

The reported event was inconclusive because no sample was returned.A potential root cause for this failure could be due to "water lost via permeation".The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: "warning: do not use ointments or lubricants having a petrolatum base.They will damage the catheter.Visually inspect the product for any imperfections or surface deterioration prior to use.¿ use luer tip syringe to inflate with stated ml of sterile water.Or ¿ for pre-filled products, remove clip and squeeze reservoir to inflate with stated ml of sterile water.Storage: store catheters at room temperature away from direct exposure to light, preferably in the original box.For urological use only.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.Allow the pressure within the balloon to force the plunger back and fill the syringe with water.If you notice slow or no deflation, re-seat the syringe gently.Use only gentle aspiration to encourage deflation if needed.Vigorous aspiration may collapse the inflation lumen, preventing balloon deflation.If necessary, 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.This is a single use device.Do not resterilize any portion of this device.Reuse and/or repackaging may create a risk of patient or user infection, compromise the structural integrity and/or essential material and design characteristics of the device, which may lead to device failure, and/or lead to injury, illness or death of the patient." h11: section a through f - the information provided by bd represents all 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 customer had been facing issues with the silastic foley catheters.They had 2 defective balloons in them.They both deflated and actually ended up having to go to an emergency.Both the catheters were from the same lot and there were 11 in total.As per the follow up information received on 13mar2024, the patient underwent a medical intervention in the emergency room.

• Brand Name: BARD® SILASTIC® FOLEY CATHETER
• Type of Device: SILASTIC FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer (Section G): C.R. BARD INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 19003448
• MDR Text Key: 338900868
• Report Number: 1018233-2024-01704
• Device Sequence Number: 1
• Product Code: EZL
• UDI-Device Identifier: 00801741020070
• UDI-Public: (01)00801741020070
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K951103
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/10/2024

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 Catalogue Number: 33618
• Device Lot Number: NGHV2944
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/08/2024
• Initial Date FDA Received: 03/29/2024
• Supplement Dates Manufacturer Received: 04/10/2024
• Supplement Dates FDA Received: 04/11/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/07/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention