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

Device Problem Obstruction of Flow (2423)

Patient Problem Vomiting (2144)

Event Date 11/07/2019

Event Type  malfunction  

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 customer reported that the patient is having issues with the g-tube becoming clogged.It was checked and fixed.The patient had an episode of emesis.The item code and lot number were not available.

• 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: 9345172
• MDR Text Key: 167584322
• Report Number: 9612030-2019-02357
• 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
• Report Date: 11/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Date Manufacturer Received: 11/09/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1