MAUDE Adverse Event Report: PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590 BARDEX 2-WAY 3CC ALL-SILICONE PEDIATRIC FOLEY CATHETER; PEDIATRIC SILICONE CATHETER

Catalog Number 165808

Device Problem Burst Container or Vessel (1074)

Patient Problem Complaint, Ill-Defined (2331)

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The device was not returned.

Event Description

It was reported that the catheter balloon burst.The complainant stated that the customer may have used too much solution to inflate the balloon as a 10 cc syringe was used to fill the 3 cc balloon.It was reported that the customer was using between 5 and 6cc of water to fill the balloon.It was unsure if any pieces were missing from the four different balloons.The patient was re-catheterized after each balloon burst.The patient allegedly "hurts" every time a catheter was inserted following the bursts.

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.The device was not returned.

Event Description

It was reported that the catheter balloon burst.The complainant stated that the customer may have used too much solution to inflate the balloon as a 10 cc syringe was used to fill the 3 cc balloon.It was reported that the customer was allegedly using between 5 and 6cc of water to fill the balloon.It has not been confirmed whether or not any pieces were missing from the four different balloons.The patient was re-catheterized after each balloon burst.The patient allegedly experiences pain every time a catheter was inserted following the bursts.

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.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 the catheter balloon burst.The complainant stated that the customer may have used too much solution to inflate the balloon, as a 10 cc syringe was used to fill the 3 cc balloon.It was reported that the customer was allegedly using between 5 and 6cc of water to fill the balloon.It has not been confirmed whether or not any pieces were missing from the four different balloons.The patient was re-catheterized after each balloon burst.Following the burst, the patient allegedly experienced pain each time a catheter was inserted.

Manufacturer Narrative

The device was not returned for evaluation.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." (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 burst.The complainant stated that the customer may have used too much solution to inflate the balloon, as a 10 cc syringe was used to fill the 3 cc balloon.It was reported that the customer was allegedly using between 5 and 6cc of water to fill the balloon.It has not been confirmed whether or not any pieces were missing from the four different balloons.The patient was re-catheterized after each balloon burst.Following the burst, the patient allegedly experienced pain each time a catheter was inserted.

• Brand Name: BARDEX 2-WAY 3CC ALL-SILICONE PEDIATRIC FOLEY CATHETER
• Type of Device: PEDIATRIC 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: 6103582
• MDR Text Key: 60306146
• Report Number: 1018233-2016-01620
• 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: distributor,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/20/2016

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: 07/31/2021
• Device Catalogue Number: 165808
• Device Lot Number: NGAQ2774
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/26/2016
• Initial Date FDA Received: 11/15/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 12/01/2016; 12/20/2016; 01/06/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/10/2016
• 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
• Patient Age: 4 YR