MAUDE Adverse Event Report: PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590 BARDEX 2-WAY 5CC ALL-SILICONE FOLEY CATHETER

Catalog Number 165814

Device Problems Difficult to Remove (1528); Failure to Advance (2524)

Patient Problem Pain (1994)

Event Date 09/15/2015

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete, a supplemental report will be filed.The information provided by bard 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 bard.

Event Description

It was reported that a 14fr catheter was difficult to remove.The foley tube was unable to pass through the end of the urethra.The patient stated that it was very painful.A doctor had to remove the last 5 cm of the foley.It was alleged that after the removal, the foley had a prominent ridge at the end.

Manufacturer Narrative

Received 1 used silicone foley catheter only.Visual evaluation noted no obvious defects on the returned catheter.There was no cuff roll present on the catheter balloon.The balloon was inflated with 10cc's of air and then deflated.After that a cuff roll was not formed.The balloon was injected with 10cc's of a mix of water and blue methylene using a syringe.The catheter was left for 3 minutes on a flat surface.When the catheter was deflated a cuff roll was not formed.The complaint was unconfirmed as the reported problem could not be reproduced.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use state the following: "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.Allow the balloon to deflate slowly on its own.Do not aspirate or manually accelerate the deflation of the balloon.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.Visually inspect the product for any imperfections or surface deterioration prior to use." (b)(4).The information provided by bard 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 bard.

Event Description

Per a visual observation on (b)(6) 2015 when the catheter was brought to the hospital's biomed department, the balloon was not in its proper shape or location.It was alleged that the balloon was folded back toward the tip.When the balloon was deflated by the hospital staff it created a ridge.The balloon was moved back to its original position by the hospital staff.According to an unknown physician at the hospital it was alleged that the catheter was inflated in the urethra which stretched the balloon, therefore causing the balloon to fold when it was deflated.It was stated by the hospital that it is not known if the incident occurred due to a failure of the device or technique of the caregiver.

• Brand Name: BARDEX 2-WAY 5CC ALL-SILICONE FOLEY CATHETER
• Type of Device: SILICONE FOLEY CATHETER
• Manufacturer (Section D): PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590; km. 7 carretera internacional; nogales, sonora 85621 ; MX 85621
• Manufacturer (Section G): PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590; km. 7 carretera internacional; nogales, sonora 85621 ; MX 85621
• Manufacturer Contact: janna parks ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 5211145
• MDR Text Key: 31053907
• Report Number: 1018233-2015-00453
• Device Sequence Number: 1
• Product Code: EZL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040504
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/14/2015

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: Health Professional
• Device Expiration Date: 11/30/2019
• Device Catalogue Number: 165814
• Device Lot Number: NGYL2554
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/23/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/16/2015
• Initial Date FDA Received: 11/09/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/06/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/26/2014
• 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
• Patient Age: 19 YR