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

Catalog Number 165816

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Irritation (1941)

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 the product developed a ridge above the balloon that caused irritation upon insertion and removal.

Manufacturer Narrative

Received one used silicone catheter.Initial visual evaluation noted no obvious defects.Per functional evaluation the balloon was inflated with air and deflated and no cuff roll was formed.After that, 10cc of a mix of water and blue methylene was introduced with a syringe, the catheter was left for 3 minutes resting in a flat surface.Then it was deflated by itself and no cuff roll was found.Per dimensional evaluation the active length was measured with a digital caliper and the results are as follows.Short side= 0.7995¿, long side=0.8160¿ (per dwg8040 the active length is 0.6¿ to 0.9¿).The catheter active length was found within specification.The reported event could was unconfirmed as the product 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 states 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.

• Brand Name: BARDEX 2-WAY 5CC ALL-SILICONE FOLEY CATHETER
• Type of Device: SILICONE 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: 5369433
• MDR Text Key: 36060138
• Report Number: 1018233-2016-00013
• 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: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/27/2016

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: 07/31/2020
• Device Catalogue Number: 165816
• Device Lot Number: NGZJ1709
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/30/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/16/2015
• Initial Date FDA Received: 01/15/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/20/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/31/2015
• 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