MAUDE Adverse Event Report: COVIDIEN 3 GA SHRPSTR II CONT TRAN RD10; SHARPS CONTAINER

Model Number 8537SA

Device Problem Device Operates Differently Than Expected (2913)

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

Event Type  malfunction  

Manufacturer Narrative

Submit date: 11/09/2016.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 sharps container.The customer states that the flip lid is staying in the up position when it is not full requiring the user to pull down the flap before tossing in the needle/syringe.There was no harm or medical intervention reported as a result.

• Brand Name: 3 GA SHRPSTR II CONT TRAN RD10
• Type of Device: SHARPS CONTAINER
• Manufacturer (Section D): COVIDIEN; 815 tek drive; crystal lake IL 60039 9002
• Manufacturer (Section G): CRYSTAL LAKE; 815 tek drive; crystal lake IL 60039 9002
• Manufacturer Contact: edward almeida ; 15 hampshire st; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 6089249
• MDR Text Key: 59969103
• Report Number: 1424643-2016-00025
• 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,distri
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/18/2016

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: Health Professional
• Device Model Number: 8537SA
• Device Catalogue Number: 8537SA
• Device Lot Number: 173442
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/18/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1