MAUDE Adverse Event Report: COVIDIEN 2 GA N/S COLL CONT YELLOW 20; CONTAINER, SHARPS

Model Number 8970Y

Device Problem Crack (1135)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/26/2019

Event Type  malfunction  

Manufacturer Narrative

The complainant indicated that the device will not be returned for evaluation; therefore, a failure analysis is not available, and we are not able to determine the relationship between this device and the cause for this event.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.If additional information or the sample is received, the investigation will be reopened and responded to accordingly.

Event Description

The customer reported when the nurse moved the sharps container with the sharps inside, she noticed the bottom of the sharps container was cracked.

Manufacturer Narrative

A review of the device history record was completed for lot 18h08463.The dhr review concluded no abnormal process conditions were present during the manufacturing of this product that would lead to the reported condition.The dhr review showed that all acceptance criteria inspections per established sampling levels were within acceptable limits during the production process.One sample was received at the plant for the investigation.A visual evaluation was performed, and the defect was confirmed, a large crack (approximately 6.5¿ across) extending from the bottom (surface c) of the container to the bottom front edge (surface b) was observed.There is not enough information available to determine a root cause; however, it is possible that during use the container was damaged when installing or uninstalling the container from a wall enclosure.It is noted in the complaint summary that there were sharps in the container when the crack was discovered.Therefore, the crack probably occurred during use and may have been caused by accidentally dropping the container and/or forcefully installing/uninstalling the container from a secondary device such as a wall enclosure.Based on the information available, trend analysis, and the investigation findings, no formal investigation will be required.No new or unexpected failure mode has been identified.

• Brand Name: 2 GA N/S COLL CONT YELLOW 20
• Type of Device: CONTAINER, SHARPS
• Manufacturer (Section D): COVIDIEN; 815 tek drive; crystal lake IL 60039 9002
• MDR Report Key: 8479843
• MDR Text Key: 141104976
• Report Number: 1424643-2019-00533
• Device Sequence Number: 1
• Product Code: MMK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 8970Y
• Device Catalogue Number: 8970Y
• Device Lot Number: 18H08463
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/29/2019
• Patient Sequence Number: 1