MAUDE Adverse Event Report: PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590 BARDEX LUBRI-SIL ALL-SILICONE FOLEY CATHETER WITH HYDROGEL COATING, 16 FR.; LUBRISIL CATHETER

Catalog Number 175816

Device Problems Fluid/Blood Leak (1250); Structural Problem (2506)

Patient Problem No Information (3190)

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 catheter balloon was asymmetrical, which caused it to leak.

Manufacturer Narrative

Received 1 used silicone catheter only.The reported event was unconfirmed, as the problem could not be reproduced.Per visual inspection no defects were found.Per functional evaluation, the catheter balloon was inflated with 15 cc of air using a syringe according to (b)(4).The catheter balloon was inflated with 10cc with a mix of tap water and blue methylene using a syringe and then deflated.An asymmetrical balloon was not observed with air and water.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: " recommended inflation capacities: a 3cc balloon: use 5ml sterile water, 5cc balloon: use 10ml sterile water, 30cc balloon: use 35ml sterile water.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

It was reported that the catheter balloon was asymmetrical.Subsequently, the device leaked.

• Brand Name: BARDEX LUBRI-SIL ALL-SILICONE FOLEY CATHETER WITH HYDROGEL COATING, 16 FR.
• Type of Device: LUBRISIL 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: amy gravley ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 6347441
• MDR Text Key: 68226720
• Report Number: 1018233-2017-00564
• 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,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/04/2017

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: 05/24/2021
• Device Catalogue Number: 175816
• Device Lot Number: NGAS1121
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/30/2017
• Initial Date FDA Received: 02/21/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/04/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/25/2016
• 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