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

Model Number	8884711253E
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pneumothorax (2012)
Date of Event	10/04/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Event or Problem Description
The customer reported that the patient was given crushed medicines via nasogastric tube (ngt), existing ngt was blocked, and it was unable to unblock, so the tube was removed.Per customer, attempt was made to re-insert a fine bore ngt, a resistance was felt, so the insertion was stopped and requested help from icu doctors.The icu doctor took over the ngt insertion and fine bore ngt was inserted, awaited chest x-ray (cxr) for confirmation of placement.The chest x-ray showed the ngt was far down patient¿s right main bronchus, a pneumothorax was noted.The ngt was pulled right back and re-inserted successfully with placement confirmed on chest x-ray and a right pigtail icc was inserted for pneumothorax.
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 11-oct-2021.Based on the information available to us, we were unable to confirm the event.In the meantime, all information received will be used for further tracking and trending purposes.

• Brand Name: DOBBHOFF 12FR 43IN W STYLET EN
• 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: 18100968
• Report Number: 9612030-2023-03853
• Device Sequence Number: 7709844
• Product Code: KNT
• UDI-Device Identifier: 10884521582927
• UDI-Public: 10884521582927
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 8884711253E
• Device Catalogue Number: 8884711253E
• Device Lot Number: 2127804064
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/27/2023
• Supplement Date Received by Manufacturer: 10/27/2023
• Initial Report FDA Received Date: 11/09/2023
• Supplement Report FDA Received Date: 12/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/11/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown