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

Catalog Number 165814

Device Problem Deflation Problem (1149)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/06/2016

Event Type  malfunction  

Manufacturer Narrative

The device was not returned for evaluation.The lot number is unknown; therefore, the device history record could not be reviewed.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.The device was not returned.

Event Description

It was reported that on (b)(6) 2016, the foley was inserted in the operating room.On day 1 post operation, the registered nurse went to deflate the balloon and allegedly got only air and then got urine back.There was no saline as there normally would be.When the foley was removed, another registered nurse re-inflated the balloon outside of the patient and it allegedly deflated and leaked.The balloon appeared intact with no visible tears or holes.

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 on (b)(6) 2016, the foley was inserted in the operating room.On day 1, post operation, the registered nurse attempted to deflate the balloon, and allegedly received a return of air, before receiving a return of urine.There was no saline, as there normally would be.When the foley was removed, another registered nurse re-inflated the balloon; outside of the patient, and it allegedly deflated and leaked.The balloon appeared intact with no visible tears or holes.

Manufacturer Narrative

Received 1 used silicone catheter.The reported event was confirmed as a manufacturing related issue.During the visual inspection no defects along the catheter were found.The functional evaluation was conducted as follows: "the catheter was inflated with air and quickly the catheter balloon was deflated.Then the catheter was tried to inflate with 10cc with a mix of water and blue methylene with a syringe and the water passed to drainage lumen from the notch perforation.Then the catheter balloon was cut and under 10x magnification it was observed that the notch is double perforated." (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 on (b)(6) 2016, the foley was inserted in the operating room.On day 1, post operation, the registered nurse attempted to deflate the balloon, and allegedly received a return of air, before receiving a return of urine.There was no saline, as there normally would be.When the foley was removed, another registered nurse re-inflated the balloon; outside of the patient, and it allegedly deflated and leaked.The balloon appeared intact with no visible tears or holes.

• Brand Name: BARDEX 2-WAY 5CC ALL-SILICONE FOLEY CATHETER, TWO OPPOSED EYES, SHORT
• 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: amy gravley ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 6211354
• MDR Text Key: 63741373
• Report Number: 1018233-2016-01879
• Device Sequence Number: 1
• Product Code: EZL
• 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: other,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/20/2017

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: Other
• Device Expiration Date: 05/31/2021
• Device Catalogue Number: 165814
• Device Lot Number: NGAS2562
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/07/2016
• Initial Date FDA Received: 12/28/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 02/15/2017; 03/15/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/03/2016
• 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