MAUDE Adverse Event Report: HALYARD HEALTH MIC* TJ FEEDING TUBE KIT 18 FR, 45CM (ENDO/RADIOL); DIGEST HEALTH EF BALLOON TUBES PRODUCTS

Model Number 0250-18

Device Problem Burst Container or Vessel (1074)

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

Event Date 09/04/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The product involved in the report has been returned and is being processed for evaluation.A review of the device history record is in-progress.Upon completion of the sample evaluation and investigation; a follow-up report will be filed.Halyard health has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the halyard health complaint database and identified as (b)(4).This information is submitted pursuant to 21 cfr 803, in compliance with the medical device reporting requirement and should not be considered to be an admission that a halyard health product is defective or caused serious injury.

Event Description

It was initially reported that the patient had "a number of tubes places of the same size and type, but balloons seem to fail within a short time." additional information received on 09/29/2015 stated that "the tube was placed on (b)(6) 2015 and then replaced in interventional radiology on (b)(6) 2015 due to balloon failure.There are no reported adverse event as it relates to the tube exchange.

Manufacturer Narrative

The device history record for the lot number involved, aa5034n19, in this complaint was reviewed and the material was produced according to the manufacturing procedures and met the quality requirements.One sample device was returned.The balloon exhibited an axial burst, extending diagonally from the base of the proximal collar to the distal tip of the device.The balloon material was inspected under magnification.No obvious defect ws observed on the material that could identify a potential point of origin for the burst.Halyard health has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the halyard health complaint database and identified as complaint (b)(4).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that a halyard health product is defective or caused serious injury.

• Type of Device: DIGEST HEALTH EF BALLOON TUBES PRODUCTS
• Manufacturer (Section D): HALYARD HEALTH; 5405 windward parkway; alpharetta GA 30004
• Manufacturer (Section G): AVENT SA DE R.L. DE C.V.; circuito industial no.40; colonia obrera; nogales 84160 ; MX 84160
• Manufacturer Contact: lisa clark ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485444
• MDR Report Key: 5125312
• MDR Text Key: 27643022
• Report Number: 9611594-2015-00162
• Device Sequence Number: 1
• Product Code: KGC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK080253
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Followup
• Report Date: 09/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other Caregivers
• Device Expiration Date: 10/30/2016
• Device Model Number: 0250-18
• Device Catalogue Number: 991095484
• Device Lot Number: AA5034N19
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/29/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/09/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1