MAUDE Adverse Event Report: COVIDIEN KANGAROO NGT WITH WEIGHTED DOBBHOFF TIP; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number UNKNOWN

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

Patient Problems Aspiration/Inhalation (1725); Pneumonia (2011)

Event Date 03/10/2019

Event Type  Injury  

Manufacturer Narrative

The incident sample has been requested but to date has not been received for evaluation.If the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted.

Event Description

The initial reporter stated that a weighted tip dobbhoff nasogastric tube was placed at curahealth in (b)(6).The product id and lot number is unknown.The patient was transferred to (b)(6) on (b)(6) 2019.On (b)(6) 2019 a nurse crushed the medication in apple sauce to administer medication by mouth because the ng tube was so thin and would easily clog.Immediately after giving the medication by mouth, the taste of crushed medication caused the patient to vomit.At approximately 1:00am on (b)(6) 2019 the patient felt his nose running.He thought he had a nose bleed.The patient got a plastic bin to place under his nose because it became more than a drip and was drizzling out of his nose at which time he noticed it was the color of the feed being delivered.As he hovered over the basin, the tube fell out of his nose into the basin.The patient then needed to be transported from cape heritage rehabilitation to cape cod hospital to have a new ng tube inserted.Upon their evaluation, they discovered the patient had aspirated and developed a minor case of pneumonia.The patient is receiving iv antibiotics, which began on (b)(6) 2019.The patient is currently still hospitalized.

• Brand Name: KANGAROO NGT WITH WEIGHTED DOBBHOFF TIP
• 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: 8414040
• MDR Text Key: 138582000
• Report Number: 9612030-2019-02120
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: UNKNOWN
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 03/10/2019
• 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 Outcome(s): Hospitalization; Required Intervention
• Patient Age: 61 YR