MAUDE Adverse Event Report: KIMBERLY-CLARK HEALTH CARE MIC GASTRO ENTERIC FEEDING TUBE, 16 FR, LV; ENTERAL FEEDING TUBE

Model Number 0210-16LV

Device Problem Split (2537)

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

Event Type  malfunction  

Event Description

Kimberly-clark received a report stating the transgastric enteral feeding tube has a small split below the jejunal port.The tube was placed on (b)(6) 2014.The tube was still in place at the time of this report.The patient was scheduled to have the tube replaced by a radiologist at a later date.There was no reported patient injury.No additional information was provided in regards to the patient's status and the outcome of the procedure.

Manufacturer Narrative

The actual complaint product was not returned for evaluation.A review of the device history record is in-progress.Upon completion of the investigation; a follow-up report will be filed.Kimberly-clark 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 kimberly-clark complaint database (b)(4).Device not returned by customer.

• Brand Name: MIC GASTRO ENTERIC FEEDING TUBE, 16 FR, LV
• Type of Device: ENTERAL FEEDING TUBE
• Manufacturer (Section D): KIMBERLY-CLARK HEALTH CARE; 1400 holcomb bridge road; roswell GA 30076
• Manufacturer (Section G): AVENT SA DE R.L. DE C.V.; circuito industial no.40; colonia obrera; nogales 8404 8; MX 84048
• Manufacturer Contact: lisa clark ; 1400 holcomb bridge road; roswell, GA 30076
• MDR Report Key: 4115909
• MDR Text Key: 4700183
• Report Number: 9611594-2014-00114
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK993138
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other Caregivers
• Type of Report: Initial
• Report Date: 08/25/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other Caregivers
• Device Expiration Date: 04/17/2017
• Device Model Number: 0210-16LV
• Device Catalogue Number: 991094987
• Device Lot Number: AA4092E01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/25/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/17/2014
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Age: 20 MO
• Patient Weight: 11