MAUDE Adverse Event Report: COVIDIEN KANGAROO; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number 461243

Device Problem Detachment Of Device Component (1104)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

The customer states that while removing the feeding tube, the distal tip got stuck in the patient's nare and was difficult to remove.After the tube was pulled out, the user found that the camera had broken off and there were exposed wires from the end of the tube.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

On (b)(6) 2018, the customer stated that the patient was stable when she left.The camera was not completely severed off, it was just attached by the internal wires.An x-ray was done and the tip of the tube was observed to be kinked.There was no resistance felt during the removal of the tube.The tube was in for only one day.There was no medical intervention required and there was no harm to the patient.

Manufacturer Narrative

Medical intervention was required.An investigation was performed for the reported customer complaint: ¿the customer states that while removing the feeding tube, the distal tip got stuck in the patient's nare and was difficult to remove.After they pulled it out they realized the camera had broken off and there were exposed wires from the end of the tube.On (b)(6) 2018, the customer stated that the patient was stable when she left.The camera was not completely severed off, it was just attached by the internal wires.An x-ray was done and the tip of the tube was observed to be kinked.There was no resistance felt during the removal of the tube.The tube was in for only one day.There was no medical intervention required and there was no harm to the patient.¿ additional information was received from the reporting health care provider indicating the patient was orally intubated and the tube was simply removed from the patient after the detached camera was discovered.No patient harm was reported.No additional information was provided.No lot number was provided.However, all dhrs are reviewed for accuracy prior to product release.In-process procedures are also in place to prevent nonconforming product in the manufacturing process.This ensures components and finished products meet all quality inspection standards.These controls include, but are not limited to: material verification/certification processes, dimensional specifications, statistical samplings, periodic audits, process inspections, machine maintenance/operation and personnel training and certification.Because there was no lot number, a date of manufacture could not be determined.This product was being used for the treatment or diagnosis.No product/sample was provided for evaluation.Therefore, a comprehensive investigation was unable to be conducted.No medical safety assessment required since severity of harm is low.The reported customer complaint is not confirmed.A root cause could not be determined.No corrective or preventive action is planned at this time.This complaint will be used for trending purposes.If information is provided in the future, a supplemental report will be issued.

• Brand Name: KANGAROO
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• Manufacturer (Section G): COVIDIEN; 15 hampshire street; mansfield MA 02048
• Manufacturer Contact: edward almeida ; 15 hampshire street; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 7616489
• MDR Text Key: 111655740
• Report Number: 1282497-2018-00511
• 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,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 461243
• Device Catalogue Number: 461243
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/01/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention