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

Model Number 165816

Device Problems Material Too Rigid or Stiff (1544); Device Operates Differently Than Expected (2913); Device Dislodged or Dislocated (2923)

Patient Problem No Code Available (3191)

Event Date 03/19/2017

Event Type  Injury  

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 facility claims that they have had "numerous" issues with these catheters.The catheters had reportedly just popped out of patients' urethras with inflated bulbs and also have had them split males penis'.These catheters were allegedly very stiff and had caused a lot of damage.

Manufacturer Narrative

Received 1 used catheter with the drainage bag still attached.The reported event was unable to be confirmed as the problem could not be reproduced.Per the visual inspection, no obvious defects were found.No manufacturing defects were observed.During the functional evaluation., the balloon was inflated with 10cc of air, using a syringe, and it did not deflate.The catheter balloon was then inflated with 10ml of a mix of tap water and blue methylene, using a syringe, and was left for 30 minutes resting on a flat surface; no deflation was found.The catheter was handled at the bifurcation area and no deflation was found.A tactile evaluation was conducted and no discrepancies were noted.The silicone material was smooth and no stiffness was found along the catheter shaft, balloon, tip area, or on the inflation and drainage arms.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 3cc balloon: use 5ml sterile water, 5cc balloon: use 10ml sterile water, 30cc balloon: use 35ml sterile water, do not exceed recommended capacities.Should balloon rupture occur, care should be taken to assure that all balloon fragments have been removed from the patient.Visually inspect the product for any imperfections or surface deterioration prior to use".

Event Description

It was reported that the facility claims that they have had "numerous" issues with these catheters.The catheters had reportedly just popped out of patients' urethras with inflated bulbs and also have had them split males penis'.These catheters were allegedly very stiff and had caused a lot of damage.

• Brand Name: BARDEX 2-WAY 5CC ALL-SILICONE FOLEY CATHETER, TWO OPPOSED EYES, SHORT
• 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: amy gravley ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 6478201
• MDR Text Key: 72335118
• Report Number: 1018233-2017-01681
• Device Sequence Number: 1
• Product Code: EZL
• UDI-Device Identifier: 00801741029752
• UDI-Public: (01)00801741029752
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K040504
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 08/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2021
• Device Model Number: 165816
• Device Catalogue Number: 165816
• Device Lot Number: NGAU4102
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/25/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/24/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/13/2016
• 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