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

Model Number 33424

Device Problems Improper or Incorrect Procedure or Method (2017); Failure to Infuse (2340)

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 inflation lumen was inflated instead of the balloon on the foley catheter.It was noted that the same issue occurred when it was deflated and inflated again during further inspection it was found that the catheter had already passed the expiry date.

Manufacturer Narrative

The reported event was unconfirmed, as the product meets the specifications.A 30cc silastic catheter was returned without its original packaging.The catheter was inflated with 35ccs of water with no inflation issues.The inflated catheter was placed in water for 1 minute and 30 seconds to check for air leaks, no air leaks were found.The catheter was then passively deflated with no issues.The device appeared to be used for the treatment.As there were no balloon inflation issues noted there does not appear to be a relationship between the device and the reported event.A dhr review and manufacturing review summary was not completed as the reported event was unconfirmed.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.".

Event Description

It was reported that the inflation lumen inflated instead of the balloon on the foley catheter.It was noted that the same issue occurred when it was deflated and inflated again during further inspection it was found that the catheter had already passed the expiry date.

• 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 GA 30014
• MDR Report Key: 10174489
• MDR Text Key: 196425823
• Report Number: 1018233-2020-03954
• Device Sequence Number: 1
• Product Code: EZL
• UDI-Device Identifier: 00801741020025
• UDI-Public: (01)00801741020025
• Combination Product (y/n): N
• PMA/PMN Number: K951103
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 09/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/30/2020
• Device Model Number: 33424
• Device Catalogue Number: 33424
• Device Lot Number: NGCQ1538
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2020
• Initial Date Manufacturer Received: 05/29/2020
• Initial Date FDA Received: 06/19/2020
• Supplement Dates Manufacturer Received: 08/14/2020
• Supplement Dates FDA Received: 09/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1