MAUDE Adverse Event Report: CARDINAL HEALTH DOBBHOFF 12FR 43IN W STYLET; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	8884711253
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/26/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.Device evaluation comment - the customer stated that the device will not be returned for evaluation because it was discarded.
Event or Problem Description
Customer reports: there is a specific problem with the covidien kangaroo nasogastric feeding tubes, namely that when one goes to pull out the stylet that the plastic cap on the stylet will pull off.This will both create a sharp that risks puncturing the operator and makes it very difficult, if not impossible, for the operator to remove the stylet.In the past, i've had to sometimes try to find a hemostat or clamp to grab and pull the stylet out when this happened.When consulted to place an ngt in this patient and demonstrating to the team the difference between a weighted feeding tube and a non-weighted feeding tube sing one of these covidien weighted feeding tubes, i demonstrated how to pull the stylet out and the stylet cap popped off, leaving me unable to pull the stylet out.This is a risk to both operator and patient safety.
Additional Manufacturer Narrative
A review of the device history record (dhr) revealed no abnormal process conditions were present during the manufacturing of the product that could have led to the condition described by the customer.The dhr review showed that all acceptance criteria inspections per established sampling levels were within acceptable limits during the production process.There were no samples received for evaluation therefore the reported condition could not be confirmed.A walk though was done by a multifunctional team to review the manufacturing process.Current process and controls were found to be followed correctly, including subassemblies, finished product assembly, packaging, and product inspections.The most likely root cause is a failure to activate the hydromer, making it difficult to remove the stylet from the feeding tube.A corrective/preventative action plan is not required since the reported condition has not been identified as manufacturing related.The current process is running according to product specifications meeting quality acceptance criteria.We will continue monitoring the process for any adverse trends that require immediate attention.

• Brand Name: DOBBHOFF 12FR 43IN W STYLET
• Common Device Name: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• 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: 15651013
• Report Number: 9612030-2022-03436
• Device Sequence Number: 6036229
• Product Code: KNT
• UDI-Device Identifier: 10884521518803
• UDI-Public: 10884521518803
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 8884711253
• Device Catalogue Number: 8884711253
• Device Lot Number: 2127803964
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/19/2022
• Supplement Date Received by Manufacturer: 10/19/2022
• Initial Report FDA Received Date: 10/21/2022
• Supplement Report FDA Received Date: 01/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Weight: 69 KG