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

Model Number 8884711253

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Chest Pain (1776); Dyspnea (1816); Low Blood Pressure/ Hypotension (1914); Tachycardia (2095); Low Oxygen Saturation (2477); No Code Available (3191)

Event Date 07/03/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).The complainant indicated that the device will not be returned for evaluation because it was discarded; therefore, a failure analysis is not available, and we are not able to determine the relationship between this device and the cause for this event.If additional information or the sample is received, the investigation will be reopened and responded to accordingly.

Event Description

The customer reported that during a follow up to the patient it was noticed in the x-ray that the ng tube appears to be in the lung.Additional information provided states that 18 hours after the procedure the patient presented respiratory symptoms and it was required to remove the ng tube.Further information provided on 13-sep-2019 stated that the (b)(6) year old patient entered with a hypertensive crisis.The patient did have an endotracheal tube in place.During insertion the head of the bed was elevated and the patient was conscious with no complaints of respiratory symptoms at that time.There was no resistance encountered during insertion.The stylet did not puncture the feeding tube nor did it get stuck during removal.The stylet was removed as usual.The placement of the tube was initially confirmed via x-ray, images of the initial x-ray are not available.Feedings were attempted prior to discovery of the tube in the lung on x-ray.The respiratory complications the patient experienced were polypnea, tachycardia, dyspnea, chest pain, blood pressure 85/45, saturation 82, heart rate 114.For medical intervention a culture and empiric antibiotic, chest plate, chest decompression was performed and surgery was indicated.The patient was discharged on (b)(6) 2019 with no follow up medical treatment planned.

• Brand Name: DOBBHOFF 12FR;43IN W/STYLET
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): COVIDIEN; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• Manufacturer (Section G): COVIDIEN; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• Manufacturer Contact: jill saraiva ; 15 hampshire street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 9070479
• MDR Text Key: 158655974
• Report Number: 9612030-2019-02264
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 10884521518803
• UDI-Public: 10884521518803
• Combination Product (y/n): N
• Reporter Country Code: CO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 8884711253
• Device Catalogue Number: 8884711253
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/21/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 80 YR