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

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

Patient Problems Septic Shock (2068); Multiple Organ Failure (3261)

Event Type  Death  

Manufacturer Narrative

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

Event Description

Per a post market clinical survey, the customer observed a death due to septic multi-organ failure with the use of a pediatric nasoenteric feeding tube with enfit.The customer stated there was a casual 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

Section b5 was updated with further details regarding the reported event.

Event Description

Per a post market clinical survey, the customer observed a death due to septic multi-organ failure with the use of a pediatric nasoenteric feeding tube with enfit.The customer stated there was a casual device relationship.The patient was reported to have other causal adverse events: diarrhea (added response ¿loose stools prolonged¿), aspiration (added response: ¿developed pneumonia¿), clogged tubes (added response: ¿happens occasionally¿), tube contamination (added response: ¿happened x3¿), abdominal discomfort, bloating and cramping (no added response), esophagitis/gastroesophageal reflux (no added response) and hemorrhage (no added response).In this case, it was reported that the device was used for 6 days before device failure, which was a failure to administer prescribed nutrition/medication/fluid due to tube blockage, occurred.Details provided indicate that the patient coughed, which led to dislodgment.The respondent rated the device use as easy, was satisfied with the safety and performance of the device, and concluded that the benefits of the use of the device did not outweigh the risks (but added ¿yes-provided safe delivery¿, which suggests that the respondent may have misunderstood the benefit/risk question.The respondent stated that the device and product worked well.This information was received via an anonymous clinical study; therefore, the customer information is unknown and no further information will be provided.

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 pediatric feeding tube products.The current process and controls were found properly followed, including sub-assemblies, finished product assembly, packaging and inspections performed to the product.Per procedure visual, dimensional, and functional inspections are performed for each lot before product release.Based on limited information from the survey response, it cannot be determined if the device may have caused or contributed to the adverse event.Furthermore, there is no reported product malfunction.Based on historical review, no non-conformances were issued related to the reported incident for any of the enteral access devices.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.No corrective actions are being pursued as a result of this complaint.This complaint will be used for tracking and trending purposes.

• 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: 15640169
• MDR Text Key: 302093172
• Report Number: 9612030-2022-03433
• Device Sequence Number: 1
• Product Code: PIF
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 11/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/11/2022
• Initial Date FDA Received: 10/20/2022
• Supplement Dates Manufacturer Received: 10/11/2022; 10/11/2022
• Supplement Dates FDA Received: 11/10/2022; 11/11/2022
• 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