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

Model Number UNKNOWN

Device Problem Insufficient Flow or Under Infusion (2182)

Patient Problem No Information (3190)

Event Date 10/24/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer reported that the machine was running but did not pump any liquid and the patient was underfed.Additional information has been requested with no response.

Manufacturer Narrative

The device history record file was reviewed indicating that product was released meeting all quality standard requirements.There were no samples received for evaluation.Because a sample was not available for evaluation, a root cause analysis could not be conducted to determine the root cause of this reported issue.If samples are received at a later date, this complaint will be re-opened and the investigation continued.This complaint will be used for tracking and trending purposes.If information is provided in the future, a supplemental report will be issued.

• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): COVIDIEN; 15 hampshire st; mansfield,ma
• Manufacturer (Section G): COVIDIEN; 15 hampshire st; mansfield,ma
• Manufacturer Contact: edward almeida ; 15 hampshire street; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 7098986
• MDR Text Key: 95078616
• Report Number: 2183870-2017-00549
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/17/2017
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1