MAUDE Adverse Event Report: COVIDIEN 2 GAL CONTAINER, TRANS YELLOW; SHARPS CONTAINER

Model Number 31300878

Device Problems Crack (1135); Out-Of-Box Failure (2311)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

An investigation is currently underway.Upon completion, the results will be forwarded.

Event Description

It was reported to covidien on (b)(6) 2016 that an issue occurred with a sharps container.Customer reports that devices were cracked.This has been occurring over time and customer has been gathering them as they arrive (damage out of box) until they had a complete case.No patient was involved.The device will be returned for evaluation.The outer box/corrugate was not damaged.The cracked containers were noticed upon inspection out of the box.Not all the containers in the box were cracked.The boxes are shipped out as cases.The customer picks up at the warehouse.The containers are cracked on the bottom.The lot number was unknown.On (b)(6) 2016, it was discovered that container with lot 159634 was cracked.

• Brand Name: 2 GAL CONTAINER, TRANS YELLOW
• Type of Device: SHARPS CONTAINER
• 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: edward almeida ; 15 hampshire st; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 6089092
• MDR Text Key: 59924753
• Report Number: 1424643-2016-00018
• Device Sequence Number: 1
• Product Code: MMK
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 08/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 31300878
• Device Catalogue Number: 31300878
• Device Lot Number: 159634
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/29/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1