MAUDE Adverse Event Report: CARDINAL HEALTH DOBBHOFF 10FR 43IN W STYLET EN; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number 8884711006E

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Foreign Body In Patient (2687); Cough (4457)

Event Date 03/03/2024

Event Type  Injury  

Event Description

The customer reported that they inserted a dobbhoff feeding tube via left nares and unable to advance for proper placement, it was curling in the back of the throat.Upon removal from nares, it was noted that the weight at the end of dobbhoff was missing.The doctor was at the bedside and stat chest xray was done followed by a stat ct scan of the chest.The patient was not in any distress.The respiration was easy and regular, on room air with oxygen (o2) saturation 100%.The report of ct scan showed that foreign object was found in left lower bronchus.The doctor spoke with the patient¿s son about possible transfer to another facility to retrieve the foreign body.Additional information was received from the customer and stated that the patient had required transfer to another facility for retrieval of the foreign object through a bronchoscopy, as the type of bronchoscopy and equipment needed is not available at heritage valley beaver.The customer further stated that the foreign body was retrieved, and the patient is doing well.

Manufacturer Narrative

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

Manufacturer Narrative

Section b5 has been updated to include additional information received via medwatch form.Section h6 (health effect - clinical code) has been updated to include cough.Section g2 report source has been updated to include the medwatch number.

Event Description

The customer reported that they inserted a dobbhoff feeding tube via left nares and unable to advance for proper placement, it was curling in the back of the throat.The patient was coughing but was not in any distress.The nurse pulled the tube out from nares without resistance, it was noted that the weight at the end of dobbhoff was missing.The doctor was at the bedside and stat chest xray was done followed by a stat ct scan of the chest.The respiration was easy and regular, on room air with oxygen (o2) saturation 100%.The report of ct scan showed that foreign object was found in left lower bronchus.The doctor spoke with the patient¿s son about possible transfer to another facility to retrieve the foreign body.Additional information was received from the customer and stated that the patient had required transfer to another facility for retrieval of the foreign object through a bronchoscopy, as the type of bronchoscopy and equipment needed is not available at heritage valley beaver.The customer further stated that the foreign body was retrieved, and the patient is doing well.

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.A picture was provided for analysis.The device was received for evaluation and the reported condition has been confirmed.A corrective and preventive action has been initiated to address the reported issue.

• Brand Name: DOBBHOFF 10FR 43IN W STYLET EN
• 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: 18867232
• MDR Text Key: 337235364
• Report Number: 9612030-2024-00046
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 10884521582903
• UDI-Public: 10884521582903
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8884711006E
• Device Catalogue Number: 8884711006E
• Device Lot Number: 2330406664
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/04/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other