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	Foreign Body In Patient (2687)
Date of Event	12/12/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on the information available to us, we were unable to confirm the event.The device history record was reviewed and indicated that the product was released accomplishing all quality standards.A corrective and preventative action was opened to further investigation this issue.In the meantime, all information received will be used for further tracking and trending purposes.
Event or Problem Description
The customer reported that after passing the probe, a foreign body was found in the patient on x-ray.After removing the probe, the same thing was without a metal tip.On (b)(6) 2024, the customer confirmed that the metal tip was referring to the weighted tip at the end of the tube.It was found in the patient's stomach.The customer stated that the tip removal method was not given to them, no information available.

• 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: 18461174
• Report Number: 9612030-2024-00004
• Device Sequence Number: 19624742
• Product Code: KNT
• UDI-Device Identifier: 10884521518803
• UDI-Public: 10884521518803
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/04/2024

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: 2209402664
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/14/2023
• Initial Report FDA Received Date: 01/06/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown