MAUDE Adverse Event Report: CARDINAL HEALTH UNKNOWN ENTERAL ACCESS; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number UNKNOWN ENTERAL ACCESS

Device Problem Material Twisted/Bent (2981)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/15/2015

Event Type  malfunction  

Event Description

The customer reported that the enteral access feeding tube was apparently obstructed.Maneuvers were performed to clear the obstruction but with no success.The device was removed and it was not obstructed but was folded (kinked).

Manufacturer Narrative

An investigation is currently underway.Upon completion, the results will be forwarded.

• Brand Name: UNKNOWN ENTERAL ACCESS
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): CARDINAL HEALTH; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• Manufacturer (Section G): CARDINAL HEALTH; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• Manufacturer Contact: jill saraiva ; 777 west street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 13153741
• MDR Text Key: 283164604
• Report Number: 9612030-2022-03129
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: UNKNOWN ENTERAL ACCESS
• Device Catalogue Number: UNKNOWN ENTERAL ACCESS
• Date Manufacturer Received: 12/13/2021
• Type of Device Usage: A
• Patient Sequence Number: 1