MAUDE Adverse Event Report: COVIDIEN 12 GAL CHEMO RED SLIDE LID; SHARPS CONTAINER

Model Number 8934CRS

Device Problem Mechanics Altered (2984)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

An investigation is currently underway.Upon completion, the results will be forwarded.

Event Description

It was reported to covidien on (b)(6) 2016 that an issue occurred with a sharps container.The customer reports that lids are not locking on.

Manufacturer Narrative

Submit date: 06/21/2017.The lot number was provided and the device history record (dhr) was reviewed indicating that the product was released accomplishing all quality standards.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.One container and lid sample was received for evaluation; there were no issues found with lid fit (it was easy to put the lid on).As there is no force requirement for lid fit, the sample performed as intended.A potential root cause identified, is the rim height of the container.This may affect the lid fit function and may potentially cause difficulty to snap the lid on the container.A corrective and preventive action (capa) has been opened to address the reported issue, which includes the adjustment of the core to improve the functional requirement of lid fit.This complaint will be used for qa tracking and trending purposes.If information is provided in the future, a supplemental report will be issued.

• Brand Name: 12 GAL CHEMO RED SLIDE LID
• Type of Device: SHARPS 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 street; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 6262038
• MDR Text Key: 65517446
• Report Number: 1424643-2017-00002
• 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: 11/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 8934CRS
• Device Catalogue Number: 8934CRS
• Device Lot Number: 00172860
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/21/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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