MAUDE Adverse Event Report: COVIDIEN 5QT.CNT.W/TRNS YELLOW CONT. 20; SHARPS CONTAINER

Model Number 8506Y

Device Problems Sticking (1597); Material Integrity Problem (2978)

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

Event Type  malfunction  

Manufacturer Narrative

An investigation is currently under way.Upon completion the results will be forwarded.

Event Description

It was reported to covidien on 11-28-2016 that a customer had an issue with a sharps container.The customer reports that with the small mouth opening, not everything is fitting properly.Small needles get stuck in the back and jam the counter balance lid.

Manufacturer Narrative

The international contact provided information stating that the customer was not using this product correctly and there was no product malfunction.The customer was under the impression that the product was a counter balance lid and the sharp/item would dispose automatically and therefore there was no product malfunction.The sales rep confirmed in servicing is being conducted.Therefore, this complaint should not have been filed and no additional reports will be submitted.

• Brand Name: 5QT.CNT.W/TRNS YELLOW CONT. 20
• 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: 6178820
• MDR Text Key: 62797551
• Report Number: 1424643-2016-00028
• 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,Followup
• Report Date: 11/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8506Y
• Device Catalogue Number: 8506Y
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/28/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1