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

Catalog Number 0167V20S

Device Problems Burst Container or Vessel (1074); Detachment of Device or Device Component (2907)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 05/31/2020

Event Type  malfunction  

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 the catheter sac ruptured and replaced immediately.The treatment was continued to find if there was any risk of infection.Per additional information received via email on 29jun2020, the detached balloon and urethral catheter was complete.

Manufacturer Narrative

The reported event was inconclusive.No sample was returned for evaluation.However, the potential root cause for this failure mode could be user related (example: contact with sharp object)/ exposure to petrolatum based products/ mechanical failure/ operator error.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: "precaution: this product contains natural rubber latex which may cause allergic reactions.Sterile unless package is opened or damaged warning: do not use petroleum substrate lubricants with the latex based urethral catheters, such as petroleum jelly and labe liquid paraffin which will damage latex and burst balloon.Water soluble lubricants can be used.Do not aspirate urine through drainage funnel wall.Single use only.Do not resterilize.For urological use only.Valve type: use luer syringe.Do not use needle.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.Use only gentle aspiration to encourage deflation if needed.Vigorous aspiration may collapse the inflation lumen.If permitted by hospital protocol, the may be cut off.If this fails, contact an 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.".

Event Description

It was reported that the catheter sac ruptured and replaced immediately.The treatment was continued to find if there was any risk of infection.Per additional information received via email on 29jun2020, the detached balloon and urethral catheter were complete.

Manufacturer Narrative

The reported event was inconclusive.No sample was returned for evaluation.However, the potential root cause for this failure mode could be user related (example: contact with sharp object)/ exposure to petrolatum based products/ mechanical failure/ operator error.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: "precaution: this product contains natural rubber latex which may cause allergic reactions.Sterile unless package is opened or damaged.Warning: do not use petroleum substrate lubricants with the latex based urethral catheters, such as petroleum jelly and labe liquid paraffin which will damage latex and burst balloon.Water soluble lubricants can be used.Do not aspirate urine through drainage funnel wall.Single use only.Do not resterilize.For urological use only.Valve type: use luer syringe.Do not use needle.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.Use only gentle aspiration to encourage deflation if needed.Vigorous aspiration may collapse the inflation lumen.If permitted by hospital protocol, the may be cut off.If this fails, contact an 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." 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.

Event Description

It was reported that the catheter sac ruptured and replaced immediately.The treatment was continued to find if there was any risk of infection.Per additional information received via email on (b)(6) 2020, the detached balloon and urethral catheter were complete.

• 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 GA 30014
• MDR Report Key: 10284897
• MDR Text Key: 199851247
• Report Number: 1018233-2020-04587
• Device Sequence Number: 1
• Product Code: MJC
• Combination Product (y/n): N
• PMA/PMN Number: K922431
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/28/2024
• Device Catalogue Number: 0167V20S
• Device Lot Number: MYDS5653
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1