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

Model Number	8884710859
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Customer reports: when the nurses inserted the feeding tube, they were unable to remove the guidewire.
Additional Manufacturer Narrative
One decontaminated dobboff 8fr with stylet within its original packaging was received for evaluation.The sample was visually checked according to product specifications.The condition reported was not able to be duplicated or confirmed as the hydromer was activated and the stylet was withdrawn without any issues.During the investigation, a thorough review of the manufacturing process was conducted.In general, all process and controls were found properly followed, including sub-assemblies, finished product assembly and packaging.There were no abnormal conditions found that could trigger the reported condition.The condition can be caused by not activating the hydromer making it difficult to remove the stylet from the feeding tube.The most likely root cause is indicative of a failure of the hydromer to activate during use making it difficult to remove the stylet from the feeding tube.The ifu instructions for the insertion of the feed tube and extraction of the stylet recommend using a syringe, to inject approximately 10 cc of water into the tube to activate the hydromer coating.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: DOBHFF 8FR;43IN W/STYLTY SITE
• Common Device Name: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): CARDINAL HEALTH; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• 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: 12837307
• Report Number: 9612030-2021-03095
• Device Sequence Number: 19942206
• Product Code: KNT
• UDI-Device Identifier: 10884521518766
• UDI-Public: 10884521518766
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/06/2022

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 Model Number: 8884710859
• Device Catalogue Number: 8884710859
• Device Lot Number: 62718864X
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/16/2021
• Supplement Date Received by Manufacturer: 11/16/2021
• Initial Report FDA Received Date: 11/18/2021
• Supplement Report FDA Received Date: 01/06/2022
• 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: Unknown