MAUDE Adverse Event Report: PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590 LUBRI-SIL 18CH, MALE 10ML WITHOUT SYRINGE; SILICONE FOLEY

Catalog Number 175818E

Device Problem Material Deformation (2976)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/01/2015

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 collar allegedly formed around the balloon site.

Manufacturer Narrative

Received 1 used silicone foley catheter with the original unit packaging.Visual inspection noted no obvious defects.During the functional evaluation the balloon was inflated with air.When the balloon was deflated a cuff roll was not formed.The balloon was then inflated with 10cc's of a mix of water and blue methylene using a syringe.The catheter balloon was left inflated for 3 minutes on a flat surface.When the balloon was deflated a cuff roll was not formed.A dimensional evaluation found that the active length of the catheter was within specifications.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The complaint was unconfirmed as the problem could not be reproduced.The instructions for use state the following: "to deflate catheter balloon: gently insert a luer slip tip syringe in the catheter valve.Never use more force than is required to make the syringe ¿stick¿ in the valve.Allow the pressure within the balloon to force the plunger back and fill the syringe with water.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, preventing balloon deflation.If necessary, contact adequately trained professional for assistance, as directed by hospital protocol." (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: LUBRI-SIL 18CH, MALE 10ML WITHOUT SYRINGE
• Type of Device: SILICONE FOLEY
• 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: 5191065
• MDR Text Key: 30369761
• Report Number: 1018233-2015-00419
• Device Sequence Number: 1
• Product Code: EZL
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K040504
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 12/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 02/27/2017
• Device Catalogue Number: 175818E
• Device Lot Number: MYXEE432
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/16/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/29/2012
• 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