MAUDE Adverse Event Report: HALYARD HEALTH MIC* TJ FEEDING TUBE KIT 22 FR, 45CM (ENDO/RADIOL); DIGESTHEALTH ENTERAL FEED TUBE KITS

Model Number 0250-22

Device Problem Burst Container or Vessel (1074)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/19/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The pink tape was removed from the sample.A "c" shape cut or tear is seen in the tubing.This is located 1cm below the base of the molded head and continues a distance of 9mm.This hole penetrates the outer wall of the tubing, into the jejunal lumen.The internal septum was examined.There is no breach of the septum between the jejunal and gastric lumens.The device history records were reviewed for lot number aa5173n16 , the product 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).

Event Description

Halyard received a single report that referenced two different incidences, which were associated with separate units, involving one patient.This is the second of two reports.Refer to mdr # 89611594-2015-00170 for the first report.It was reported by a physician that on two occasions the jejunal portion of the transgastric jejunal tube fractured at the proximal portion just distal to the jejunal port area.The first tube was inserted on (b)(6) 2015 and the fracture occurred on (b)(6) 2015.The tube was replaced on 08/28/2015 and the incidence occurred again on (b)(6) 2015.There has been no patient injury or adverse effects.

• Type of Device: DIGESTHEALTH ENTERAL FEED TUBE KITS
• 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, mexico 84048 ; MX 84048
• Manufacturer Contact: lisa clark ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485444
• MDR Report Key: 5169571
• MDR Text Key: 29413035
• Report Number: 9611594-2015-00177
• 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: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 04/29/2016
• Device Model Number: 0250-22
• Device Catalogue Number: 991095487
• Device Lot Number: AA5173N16
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/22/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/29/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1