MAUDE Adverse Event Report: COVIDIEN SHARPSAFETY; CONTAINER, SHARPS

Model Number 8939CRS

Device Problem Detachment Of Device Component (1104)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Submit date: 12/20/2017.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 when the transporter took this full container to bring it in his truck the lid removed from the container.

Manufacturer Narrative

Product 8939crs evaluated for the report of a lid fit issue.The reported condition cannot be observed as there were no photographs or physical samples submitted for a sample evaluation.Device history records data cannot be reviewed as lot number was not provided.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) was opened 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: SHARPSAFETY
• 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: 7135088
• MDR Text Key: 95475458
• Report Number: 1424643-2017-05036
• 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: 01/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 8939CRS
• Device Catalogue Number: 8939CRS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/28/2017
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1