MAUDE Adverse Event Report: COVIDIEN 3GA ALWAYS OPEN INROOM -T RED; CONTAINER, SHARPS

Model Number 85221R

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

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.The manufacturing site performed a visual inspection of the sample received.During their evaluation, the investigator observed that the lid was cracked.The root cause of the cracked lid could not be determined.Therefore, a corrective and preventive action (capa) is not applicable at this time.A quality alert will be issued for the observed issue.We will keep monitoring the process for any adverse trends that require immediate attention.This complaint will be used for qa tracking and trending purposes.

Event Description

The manufacturing site performed a visual inspection of the sample received on (b)(6) 2020.During their evaluation, the investigator observed that the lid was cracked.

• Brand Name: 3GA ALWAYS OPEN INROOM -T RED
• Type of Device: CONTAINER, SHARPS
• 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: jill saraiva ; 15 hampshire street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 10867922
• MDR Text Key: 217106961
• Report Number: 1424643-2020-00585
• Device Sequence Number: 1
• Product Code: MMK
• UDI-Device Identifier: 10884521023369
• UDI-Public: 10884521023369
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 85221R
• Device Catalogue Number: 85221R
• Device Lot Number: 20C07463
• Initial Date Manufacturer Received: 10/28/2020
• Initial Date FDA Received: 11/19/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1