MAUDE Adverse Event Report: CARDINAL HEALTH DOBBHOFF 8FR 43IN W STYLTY SI; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	8884710859E
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Event or Problem Description
The customer reported an 8 french dobhoff tube was placed in the patient, and it was verified by xray.They were unable to withdraw the guidewire.A second attempt was made to place the dobhoff, which was verified by xray, but still was unable to pull the guidewire.The night rn attempted to remove the guidewire but was unable to so they replaced it with a 12 french dobhoff and successfully were able to pull the guidewire.Order in for verification of placement to begin tube feedings.The patient tolerated the 3rd attempt well.Tube feedings to continue after verification of placement.
Additional Manufacturer Narrative
The device history record (dhr) was reviewed showing that manufacturing and inspection of product was performed as per applicable procedures and validated process.One sample was received for evaluation.The hydromer was activated with approximately 10ccs of water, and the stylet was removed without problem.A failure to activate the hydromer would make it difficult to remove the stylet from the feeding tube.The investigation was carried out with the multifunctional team.All processes and controls were found to be followed correctly.No action plan is required at this point.The manufacturing site will continue to monitor customer complaints and feedback notifications for adverse trends that require immediate attention.

• Brand Name: DOBBHOFF 8FR 43IN W STYLTY SI
• 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: 17078443
• Report Number: 9612030-2023-03718
• Device Sequence Number: 6273654
• Product Code: KNT
• UDI-Device Identifier: 10884521582880
• UDI-Public: 10884521582880
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/03/2023

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: 8884710859E
• Device Catalogue Number: 8884710859E
• Device Lot Number: 2301007464
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/01/2023
• Supplement Date Received by Manufacturer: 06/01/2023
• Initial Report FDA Received Date: 06/07/2023
• Supplement Report FDA Received Date: 08/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/16/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown