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

Catalog Number 1853SI22

Device Problem Illegible Information (4050)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/22/2022

Event Type  malfunction  

Event Description

It was reported that the customer mentioned pain when asked about the complications while using the 3-way hydrogel coated prostatic catheter.It was also stated that when the customer was asked if the instructions for use provided sufficient information and its medical applications while using the 3-way hydrogel coated prostatic catheter, they stated no because of the scheme of care and uses.

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 customer mentioned pain when asked about the complications while using the 3-way hydrogel coated prostatic catheter.It was also stated that when the customer was asked if the instructions for use provided sufficient information and its medical applications while using the 3-way hydrogel coated prostatic catheter, they stated no because of the scheme of care and uses.No medical intervention was reported.

Manufacturer Narrative

The reported event was inconclusive.No sample was returned for evaluation.A potential root cause for this failure could be ¿missing instructions¿.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: ¿warning: do not use ointments or lubricants having a petrolatum base.They will damage latex.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.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.

• Brand Name: BARDEX® I.C. FOLEY CATHETER
• Type of Device: 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: juan velez ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 14117433
• MDR Text Key: 289320053
• Report Number: 1018233-2022-02504
• Device Sequence Number: 1
• Product Code: MJC
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K910318
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1853SI22
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Other