MAUDE Adverse Event Report: COVIDIEN 2GA HORIZONTAL DROP CONT - RED; CONTAINER, SHARPS

Model Number 89651

Device Problem Crack (1135)

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

Event Date 02/26/2020

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 there were cracks on the lid and body of the container.

• Brand Name: 2GA HORIZONTAL DROP CONT - RED
• Type of Device: CONTAINER, SHARPS
• Manufacturer (Section D): COVIDIEN; 815 tek drive; crystal lake IL 60039 9002
• Manufacturer (Section G): COVIDIEN; 815 tek drive; crystal lake IL 60039 9002
• Manufacturer Contact: jill saraiva ; 15 hampshire street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 9772233
• MDR Text Key: 181539982
• Report Number: 1424643-2020-00570
• Device Sequence Number: 1
• Product Code: MMK
• UDI-Device Identifier: 40884521022226
• UDI-Public: 40884521022226
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/28/2020

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: 89651
• Device Catalogue Number: 89651
• Initial Date Manufacturer Received: 02/27/2020
• Initial Date FDA Received: 02/28/2020
• Was Device Evaluated by Manufacturer?: No
• Type of Device Usage: N
• Patient Sequence Number: 1