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

Model Number 8884711253

Device Problems Use of Device Problem (1670); Migration (4003)

Patient Problem Pneumothorax (2012)

Event Date 04/08/2022

Event Type  Injury  

Manufacturer Narrative

An investigation is currently underway.Upon completion, the results will be forwarded.

Event Description

The customer stated that they have a 2-step verification process of x-rays for inserting a nasogastric (ng) tube, the doctor only performed one of the x-rays and the ng tube perforated the lung.The patient in question got covid and then covid pneumonia and died.The patient also had many co-morbidities.The customer wants to work with cardinal health to make this a safer process by putting alert stickers on the packaging to refer to hospital protocol before insertion.She further stated that there was no dfu in the package.Per customer, the direction for activating the polymer was not noticeable.The customer is not holding cardinal health accountable and according to the customer, it is a doctor insertion issue.Additional information was received from the customer and stated that on 08-apr-2022, the patient required a pigtail chest tube inserted, because of the right tension pneumothorax that was seen on chest x-ray after the ng (ko) tube insertion.On 10-apr-2022, the patient was transferred to the intensive care unit (icu) because of tachypnea, increased work of breathing and decreased level of consciousness (loc), required optiflow.Per customer, the pigtail chest tube remained in until (b)(6) 2022.The patient was already back on the ward and deteriorated again on (b)(6) 2022, due to potential aspiration pneumonia (new hypoxia, fever, and tachycardia).The patient died on (b)(6) 2022.The death certificate states that immediate cause of death as complications of blunt trauma, antecedent fall down the stair.The other significant conditions listed was covid-19, pneumonia.Per customer, the death certificate was signed by the coroner and no autopsy held.

Manufacturer Narrative

Since a lot number was not provided, the device history record review could not be performed.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.Three (3) pictures were provided for the analysis.The pictures provided were stated as representative to the product code that was used during the incident reported.Upon reviewing the pictures, the instructions for activating the hydromer can be seen on the polybag "activate hydromer coating prior to style removal".A gemba walk was performed, and manufacturing process was reviewed, all process and controls were found properly followed, including sub-assemblies, finished product assembly, packaging and inspections performed to the product.In addition, quality control (qc) inspections are performed to the product for material release; and production personnel performs a 100% visual inspection during the packaging process, to detect and discard any identified issues.Based on the review performed, one (1) ifu is included per case (10 units) as per procedure.A physical sample was not received for the investigation.Per customer, the sample was discarded.Because a sample was not returned, we were unable to perform a follow up investigation to include functional and visual evaluations to confirm the issue and root cause analysis.At this time, a corrective and preventive action is not deemed necessary.The current process is running according to product specifications, meeting all quality acceptance criteria.We will keep monitoring the process for any adverse trends that require immediate attention.This complaint will be used for qa tracking and trending purposes.

• 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: 14567478
• MDR Text Key: 293379394
• Report Number: 9612030-2022-03269
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 10884521518803
• UDI-Public: 10884521518803
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date: 07/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 8884711253
• Device Catalogue Number: 8884711253
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Male