MAUDE Adverse Event Report: COVIDIEN RCRA HAZARDOUS WASTE CONTAINER; CONTAINER, SHARPS

Model Number 8612RC

Device Problem Fitting Problem (2183)

Patient Problem No Patient Involvement (2645)

Event Date 04/03/2017

Event Type  malfunction  

Manufacturer Narrative

Submit date: 1/15/2018.An investigation is currently under way; upon completion the results will be forwarded.If information is provided in the future, a supplemental report will be issued.

Event Description

The customer reports that the tops will not secure.This occurred during testing.

Manufacturer Narrative

The product 8612rc evaluated for the lid fit issue.The reported condition cannot be observed as there were no photographs or physical samples submitted for a sample evaluation.The device history record (dhr) review cannot be performed as lot number information is not available.The most probable root cause is that a tool that is used during the manufacturing process for the lid has a larger rim height than the tool used for the base, which causes the lid locks to be difficult to secure around the rim.A formal corrective and preventative action (capa) for more details for corrective and preventive action to address the tool used for the container.The capa has already been implemented and corrective actions are progressing as planned.As for this complaint the lot number is unknown therefore it cannot be determined when was the product manufactured.If information is provided in the future, a supplemental report will be issued.

• Brand Name: RCRA HAZARDOUS WASTE CONTAINER
• Type of Device: CONTAINER, SHARPS
• Manufacturer (Section D): COVIDIEN; 815 tek dr; crystal lake IL 60014 8172
• Manufacturer (Section G): COVIDIEN; 815 tek dr; crystal lake IL 60014 8172
• Manufacturer Contact: edward almeida ; 15 hampshire street; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 7190574
• MDR Text Key: 97427497
• Report Number: 1424643-2018-00001
• 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: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8612RC
• Device Catalogue Number: 8612RC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/03/2017
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1