MAUDE Adverse Event Report: HALYARD HEALTH MIC* TJ FEEDING TUBE KIT 18 FR, 45CM (ENDO/RADIOL); DIGESTHEALTH ENTERAL FEED TUBE KITS

Model Number 0250-18

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Unspecified Infection (1930)

Event Date 11/13/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The actual complaint product was returned for evaluation.The device history record for the lot number, aa523n10, involved in this complaint was reviewed and the material was produced according to the manufacturing procedures and met the quality requirements.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).Device not returned.

Event Description

It was reported by a caregiver that the stoma site became infected.The caregiver stated that on (b)(6) 2015 the patient began complaining of some pain around the stoma site.The site was red with noted increased drainage.The caregiver stated that the drainage looked bloody and cream colored.The caregiver spoke with the nurse practitioner at the doctors office and the patient was taken in for an office visit.The patient did not feel well, developed a temperature 101 degrees fahrenheit and was taken to the emergency room.The patient was diagnosed with a stoma infection.No additional information provided was provided.

• 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: 5275012
• MDR Text Key: 33377424
• Report Number: 9611594-2015-00234
• 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: consumer,health professional
• Reporter Occupation: Other Caregivers
• Type of Report: Initial
• Report Date: 11/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other Health Care Professional
• Device Expiration Date: 08/31/2017
• Device Model Number: 0250-18
• Device Catalogue Number: 991095484
• Device Lot Number: AA5232N10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/17/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/27/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other