MAUDE Adverse Event Report: COVIDIEN 3 GA SHARPSTAR II CONT CLR 10; SHARPS CONTAINER

Model Number 8536SA

Device Problems Bent (1059); Sticking (1597); Device Operates Differently Than Expected (2913)

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 (b)(6) 2016 that a customer had an issue with a syringe.The customer reports that the flip top lid is sticking and the needles are not falling into the container.It appears the back of the top of the box is bent and doesn't allow the flip top portion of the box to flip completely back to dispose of the needle.

• Brand Name: 3 GA SHARPSTAR II CONT CLR 10
• 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: 5967441
• MDR Text Key: 55678807
• Report Number: 1424643-2016-00013
• Device Sequence Number: 1
• Product Code: MMK
• 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,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 8536SA
• Device Catalogue Number: 8536SA
• Device Lot Number: (01) 10884521023536
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/10/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1