MAUDE Adverse Event Report: COVIDIEN MONOJECT 14QT CT CONT- RED; CONTAINER, SHARPS

Model Number 8881676434

Device Problem Difficult to Open or Close (2921)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The complainant indicated that the device will not be returned for evaluation; therefore, a failure analysis is not available, and we are not able to determine the relationship between this device and the cause for this event.  if additional information or the sample is received, the investigation will be reopened and responded to accordingly.

Event Description

The customer reported that the tabs are breaking.Additional information received from the initial reporter stated that tabs are breaking means the lid would not be able to lock in place.There was no reported injury.

• Brand Name: MONOJECT 14QT CT CONT- RED
• Type of Device: CONTAINER, SHARPS
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• Manufacturer (Section G): COVIDIEN; 15 hampshire street; mansfield MA 02048
• Manufacturer Contact: jill saraiva ; 15 hampshire street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 10891529
• MDR Text Key: 217938809
• Report Number: 1282497-2020-09655
• Device Sequence Number: 1
• Product Code: MMK
• UDI-Device Identifier: 10884521018877
• UDI-Public: 10884521018877
• 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,distri
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 8881676434
• Device Catalogue Number: 8881676434
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/06/2020
• Initial Date FDA Received: 11/24/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1