MAUDE Adverse Event Report: CARDINAL HEALTH DOBBHOFF 8FR 55 W STYLET; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	8884710826
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/31/2022
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 they were unable to pull the guidewire out after the xray.The guidewire was stuck, so they pulled the whole ng tube out and replaced it with another.This issue happened three times.
Additional Manufacturer Narrative
The device history record (dhr) review could not be performed because a lot number was not available.A sample analysis could not be performed because no photo or sample was received.The complaint will be reopened if a sample is received.The reported condition could not be confirmed.The root cause could not be determined without a sample to evaluate.The instructions for use state the proper procedure for insertion of the feed tube and extraction of the stylet.A risk assessment was performed to determine the occurrence of the reported failure mode.The observed occurrence is below the range of the expected occurrence; therefore, no action plan is required at this point.This complaint will be used for tracking and trending purposes.

• Brand Name: DOBBHOFF 8FR 55 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: 14631204
• Report Number: 9612030-2022-03270
• Device Sequence Number: 14362271
• Product Code: KNT
• UDI-Device Identifier: 10884521518742
• UDI-Public: 10884521518742
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/23/2022

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
• Operator of Device: Health Professional
• Device Model Number: 8884710826
• Device Catalogue Number: 8884710826
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/31/2022
• Supplement Date Received by Manufacturer: 05/31/2022
• Initial Report FDA Received Date: 06/08/2022
• Supplement Report FDA Received Date: 06/23/2022
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown