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

Catalog Number 0165SI14

Device Problem Illegible Information (4050)

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

Event Date 10/19/2022

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 survey respondent stated no, the instructions for use (ifu) did not provide sufficient information about the product and its medical application when asked if they would agree with the statement: the instructions for use (ifu) for the following bard/becton dickinson products provides sufficient information about the products and its or their medical applications in relation to bardex i.C.Aquafil for the european community (d236512s to d236522s french size 12,14,16,18,20,22), bardex® i.C.2-way council tip foley catheter (strip pack) (18 french) and bardex® i.C.2-way council tip foley catheter trays.Also stated no, the benefits of using this product do not outweigh the potential risks when asked if they believe that the benefits of using the bard/becton dickinson i.C.Foley catheter and/or comprehensive care tray outweigh the potential risks referring to the pros outweigh the cons in relation to bardex i.C.Female length, 2-way foley catheter (14 french) and bardex® i.C.Aquafil for the european community (24 french).

Manufacturer Narrative

The reported event was inconclusive because no sample was returned.A potential root cause for this failure could be due to "missing instructions; vendor/printer error".It is unknown whether the device had met relevant specifications.The product was used for treatment purposes.It was unknown whether the product had caused the reported failure.The dhr review could not be performed without a lot number.The instructions for use were found adequate and state the following: directions for use: 1.Visually inspect the product for any imperfections or surface deterioration prior to use.If package is opened or if any imperfection or surface deterioration is observed, do not use.2.Using proper aseptic methods, remove catheter from package.3.Prepare patient per hospital/nursing recommended procedure.4.Proceed with catheterization using standard techniques.5.Inflate the 10ml balloon with a maximum of 10ml sterile water by using a water-filled luer-tip syringe.Do not use a needle tip syringe to inflate balloon.6.Connect catheter to collection container.7.To deflate the 10ml balloon, gently reinsert the luer tip syringe into the valve and aspirate.Caution: 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 in 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 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.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.Valve type: use luer slip tip syringe.Do not use needle.Recommended inflation capacities 5ml balloon: use 5ml sterile water 10ml balloon: use 10ml sterile water 30ml balloon: use 35ml sterile water do not exceed recommended capacities.Caution: federal (u.S.A.) law restricts this device to sale by or on the order of a physician.Storage: store catheters at room temperature away from direct exposure to light, preferably in the original box.Caution: do not aspirate urine through drainage funnel wall.Warning: on catheter, do not use ointments or lubricants having a petrolatum base.They will damage latex and may cause balloon to burst.After use, this product may be a potential biohazard.Handle and dispose of in accordance with accepted medical practice and applicable local, state and federal laws and regulations.Caution: this product contains natural rubber latex which may cause allergic reactions.Sterile unless package is opened or damaged.Do not use if package is damaged.Recommended indwelling time not to exceed 28 days.Correction: g 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 survey respondent stated no, the instructions for use (ifu) did not provide sufficient information about the product and its medical application when asked if they would agree with the statement: the instructions for use (ifu) for the following bard/becton dickinson products provides sufficient information about the products and its or their medical applications in relation to bardex i.C.Aquafil for the european community (d236512s to d236522s french size 12,14,16,18,20,22), bardex® i.C.2-way council tip foley catheter (strip pack) (18 french) and bardex® i.C.2-way council tip foley catheter trays.Also stated no, the benefits of using this product do not outweigh the potential risks when asked if they believe that the benefits of using the bard/becton dickinson i.C.Foley catheter and/or comprehensive care tray outweigh the potential risks referring to the pros outweigh the cons in relation to bardex i.C.Female length, 2-way foley catheter (14 french) and bardex® i.C.Aquafil for the european community (24 french).Per follow-up information received via ibc on 15nov2022, customer stated that a leaflet to explain how it was used would be helpful.Booklet did not provide that information for new starters or students.

• 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: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 15730122
• MDR Text Key: 307162864
• Report Number: 1018233-2022-08353
• Device Sequence Number: 1
• Product Code: MJC
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K910318
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Study
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 0165SI14
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/06/2023
• 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