MAUDE Adverse Event Report: CARDINAL HEALTH; GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Type  Death  

Event Description

Per a post market clinical survey, the customer observed a death due to complications from allergies with the use of a kangaroo nj feeding tube with enfit.The customer stated there was a possible device relationship.This information was received via an anonymous clinical study; therefore, the customer information is unknown and no further information will be provided.

Manufacturer Narrative

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

Manufacturer Narrative

A sample analysis could not be performed since no photo or physical sample was available for evaluation.Although the lot number was unknown for this incident, our device history records (dhrs) are reviewed for quality inspections and parameter compliance prior to releasing the product for distribution.Based on the complaint description provided, the investigation was focused on the process for kangaroo nj feeding tube with enfit products.The current process and controls were found properly followed, including sub-assemblies, finished product assembly, packaging and inspections performed to the product.A review of the instructions for use (ifu) labels for the naso-jejunal feeding tube and the naso-jejunal feeding and gastric decompression tube show that the ifus state the devices are not recommended for patients who have anatomic anomalies or diseases of the nose, throat, or esophagus.The ifus further state that the use of this product is contraindicated in patients with known sensitivities or allergies to its components.At this time it is not possible to determine an exact root cause or confirm that the reported event is related to the cardinal health manufacturing process.Based on the above assessment, no corrective actions are being pursued as a result of this complaint.However this complaint will be used for tracking and trending purposes.

Manufacturer Narrative

Additional information was added to section b7 other relevant history, including preexisting medical conditions.

• Type of Device: GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS
• Manufacturer (Section D): CARDINAL HEALTH; 777 west street; mansfield MA 02048
• 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: 15639622
• MDR Text Key: 302085706
• Report Number: 9612030-2022-03431
• Device Sequence Number: 1
• Product Code: PIF
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 11/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Death