MAUDE Adverse Event Report: COVIDIEN TURKEL; GENERAL SURGERY TRAY

Model Number 8888567032

Device Problems Malposition of Device (2616); Appropriate Term/Code Not Available (3191)

Patient Problems Death (1802); Internal Organ Perforation (1987)

Event Type  Death  

Manufacturer Narrative

Submit date: 8/2/2018 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.If information is provided in the future, a supplemental report will be issued.

Event Description

The customer states that three covidien turkel test tubes perforated through a baby's lung tissue as per their autopsy.

Manufacturer Narrative

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

• Brand Name: TURKEL
• Type of Device: GENERAL SURGERY TRAY
• Manufacturer (Section D): COVIDIEN; boulevard insurgentes 19030; tijuana 22225 ; MX 22225
• Manufacturer (Section G): COVIDIEN; boulevard insurgentes 19030; tijuana 22225 ; MX 22225
• Manufacturer Contact: edward almeida ; 15 hampshire street; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 7749176
• MDR Text Key: 116035036
• Report Number: 1282497-2018-00646
• Device Sequence Number: 0
• Product Code: LRO
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8888567032
• Device Catalogue Number: 8888567032
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/08/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Death