MAUDE Adverse Event Report: KENTEC MEDICAL, INC. AMERITUS ENFIT ENTERAL FEEDING TUBE

Model Number ENF-Y50P-40

Device Problems Nonstandard Device (1420); Positioning Problem (3009)

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

Event Date 06/22/2017

Event Type  malfunction  

Manufacturer Narrative

The supplier of the raw materials that composes the radiopaque portion of the tubing, inadequately mixed the proportions of raw materials together, resulting in the radiopaque capacity to be compromised.Upon complaint investigation, the contract manufacturer opened a capa to establish and implement procedures to verify the radiopaque capacity of the tubing to assure that the problem does not reoccur.At this time, the capa is still ongoing.

Event Description

Indwelling feeding tube was not visible under xray.

• Brand Name: AMERITUS ENFIT ENTERAL FEEDING TUBE
• Type of Device: FEEDING TUBE
• Manufacturer (Section D): KENTEC MEDICAL, INC.; 17871 fitch; irvine CA 92614
• Manufacturer Contact: keith rooks ; 17871 fitch; irvine, CA 92614 ; 9498630810
• MDR Report Key: 6678454
• MDR Text Key: 78846075
• Report Number: 2080225-2017-06031
• Device Sequence Number: 1
• Product Code: FPD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K100526
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Nurse
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 06/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 07/01/2019
• Device Model Number: ENF-Y50P-40
• Device Catalogue Number: ENF-Y50P-40
• Device Lot Number: KS1608011
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/22/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 5 DA