MAUDE Adverse Event Report: COVIDIEN 2 GALLON CHEMO RED; CHEMO CONTAINER

Model Number 8982CRH

Device Problems Component Falling (1105); Device Tipped Over (2589); Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Submit date: 9/14/2016.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 chemo container.Customer reports that they are having issue with the way the container is designed.It can tip over easily and even when it's not at the fill mark, needles poke out.Sharps container is intended to have one side of the lid wide open and nbsp.The free standing containers can tip over on carts or fall off table tops.When they fall, the hinged lid easily opens and chemo sharps end up on the floor.

Manufacturer Narrative

Submit date: 11/30/2016.A device history record review could not be performed because a lot number was not received with the complaint.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.A photo was provided for evaluation however from the photo, the lid fit and lid detachment cannot be evaluated.The reported condition is not confirmed as the physical sample was not available for evaluation.Based on the available information, the probable root cause could be due to failure to snap lid on the container with hinged lid open.Also, since half of the lid is open, the container has to be stable during use to avoid any spills.As per the complaint description no tray holder used with the device, the container was free standing on carts or table tops.It is recommended that 2g product shall be used with tray holder for stability during use.Based on the existing controls, the internal reject and the complaint history review, no formal investigation is required at this time.This issue has been determined to be an isolated event as product has to be used as per manufacturing guideline.It is recommended that 2g product shall be used with tray holder for stability during use.

• Brand Name: 2 GALLON CHEMO RED
• Type of Device: CHEMO 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: 5951274
• MDR Text Key: 55008669
• Report Number: 1424643-2016-00012
• 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: 08/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8982CRH
• Device Catalogue Number: 8982CRH
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/30/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1