MAUDE Adverse Event Report: HALYARD HEALTH MIC-KEY* LOW-PROFILE TRANSGASTRIC-JEJUNAL FEEDING TUBE, 16 FR, 1.5 CM, 30 CM; ENTERAL FEEDING TUBE

Model Number 0270-16-1.5-30

Device Problem Split (2537)

Patient Problems Aspiration/Inhalation (1725); Pneumonia (2011)

Event Date 07/22/2015

Event Type  Injury  

Manufacturer Narrative

Patient code: aspiration, (b)(4); pneumonia, (b)(4); device code: balloon, (b)(4); split, (b)(4).The actual complaint product was not returned 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 complaint (b)(4).

Event Description

A report was received from (b)(6) stating the enteral feeding tube was found to be split underneath the balloon.The spilt in the device allowed for gastric feeding as opposed to jejunal which caused the patient to aspirate.The patient developed aspiration pneumonia.The device was used for 2-weeks prior to the event.Lubricant was used on the balloon when placing the device but the name of the lubricant was unknown.Medical intervention was required to replace the device.Placement of the device was on (b)(6) 2015.A split formed along the exterior of the tubing through to the jejunal lumen, beginning just below the balloon and approx.1cm in length.The split was detected under radiological observation with the use of contrast solution, which was instilled through the jejunal port, and confirmed the fluid as dispersing into the stomach via the split in the tube.

Manufacturer Narrative

The actual complaint product was not returned for evaluation.The device history record for the reported lot number, aa5034n13, was reviewed and documented that the lot was manufactured according to the approved manufacturing procedures, specifications, and then released by quality assurance.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).

• Type of Device: ENTERAL FEEDING TUBE
• 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 84048 ; MX 84048
• Manufacturer Contact: lisa clark ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485444
• MDR Report Key: 5020417
• MDR Text Key: 23662447
• Report Number: 9611594-2015-00144
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: PK922667
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Nurse
• Report Date: 09/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 02/28/2017
• Device Model Number: 0270-16-1.5-30
• Device Catalogue Number: 991095498
• Device Lot Number: AA5034N13
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/17/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/24/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention