MAUDE Adverse Event Report: CARDINAL HEALTH DOBBHOFF 12FR 43IN W STYLET; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number 8884711253

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/12/2023

Event Type  malfunction  

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 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
• Type of Device: 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
• MDR Text Key: 332729189
• Report Number: 9612030-2024-00004
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 10884521518803
• UDI-Public: 10884521518803
• Combination Product (y/n): N
• Reporter Country Code: BR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2024
• 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
• Date Manufacturer Received: 12/14/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1