MAUDE Adverse Event Report: COVIDIEN 12GAL CONT CHEMO W/ WHI HNGD LID X10; CHEMO CONTAINER

Model Number 8931

Device Problems Break (1069); Crack (1135); Out-Of-Box Failure (2311); Packaging Problem (3007)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Submit date: 08/16/2016.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.The customer reports that within the case 2 of the containers had broken corners.No damage to the outside case.The product was not repacked.The end customer noticed the cracks upon inspection.The bottom corners was where the cracks were located.

Manufacturer Narrative

A device history record review of the reported lot number confirmed that the product was produced accomplishing quality requirements and released according to established procedures.This issue has been determined to be an event with minimal risk as damaged container should not be used.Before use container/lid needs to be inspected for any damage as per ifu.The potential root cause has been determined to be container broken during shipping and handling due to external stress/forces.Based on the existing controls, the internal reject and the complaint history review, no formal investigation is required at this time.The capa decision tool score is low so no further action required.This issue has been determined to be an event with minimal risk as cracked container should not be used.

• Brand Name: 12GAL CONT CHEMO W/ WHI HNGD LID X10
• 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 60014 9002
• Manufacturer Contact: edward almeida ; 15 hampshire st.; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 5880079
• MDR Text Key: 53094883
• Report Number: 1424643-2016-00011
• 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: distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 8931
• Device Catalogue Number: 8931
• Device Lot Number: 00170393
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/19/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/04/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1