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

Model Number	8884710859E
Medical Device Problem Codes	Difficult to Remove (1528); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/14/2022
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 that the guidewire was tested before placing the probe, but once it was placed it could not be removed and even broke.There was no injury or associated complications reported.
Additional Manufacturer Narrative
The lot number was provided, and the device history record (dhr) was reviewed indicating that the product was released accomplishing all quality standards.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.The device was manufactured on 26nov2020.No sample have been received for the analysis.However, a picture was provided.Upon reviewing the picture, the reported condition was confirmed.The disassembly of the hub to the style was observed through the picture provided; however, the customer did not mention whether the hydromer was activated for proper removal of the style.A gemba walk was performed at the manufacturing process.All process and controls were found properly followed, including sub-assemblies, finished product assembly, packaging and inspections performed to the product.In addition, quality control (qc) inspections are performed to the product for material release that include a visual inspection sampling to verify the correct assembly from device, as well a 100% visual inspection perform by personnel production during the process, to detect and discard any identified issues.The most likely root cause indicates that this issue could have occurred due to the inadequate use of the procedure if the instructions of use are not followed.A failure to activate the hydromer makes difficult to remove the stylet from the feeding tube.Please refer to the ifu (instructions for use) for the proper procedure for insertion of the feed tube and extraction of the stylet: "using a syringe, inject approximately 10 cc of water into the tube to activate the hydromer coating".No action plan is deemed required at this time.We will keep monitoring the process for any 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: 15432409
• Report Number: 9612030-2022-03390
• Device Sequence Number: 6071074
• Product Code: KNT
• UDI-Device Identifier: 10884521582880
• UDI-Public: 10884521582880
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/10/2022

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 Expiration Date: 10/31/2025
• Device Model Number: 8884710859E
• Device Catalogue Number: 8884710859E
• Device Lot Number: 2032210164
• 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: 09/14/2022
• Supplement Date Received by Manufacturer: 09/14/2022
• Initial Report FDA Received Date: 09/15/2022
• Supplement Report FDA Received Date: 11/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/26/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Age: 84 YR
• Patient Sex: Female