MAUDE Adverse Event Report: COVIDIEN 8 GA GASKETED SLIDE LID - RED; CONTAINER, SHARPS

Model Number 8997S

Device Problem Difficult to Open or Close (2921)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/15/2020

Event Type  malfunction  

Manufacturer Narrative

The incident sample has been requested but to date has not been received for evaluation.If the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.

Event Description

The customer reported that the lid does not fit well.There was no patient or staff harm.

Manufacturer Narrative

E1 initial reporter name, email address, and phone number was corrected.

Manufacturer Narrative

Additional information the device history record (dhr) review showed that all acceptance criteria inspections per established sampling levels were within acceptable limits during the production process.Two videos and photographs provided by the customer were reviewed.No manufacturing problem was detected with the devices.The photos and video show all locking lugs are engaged.A visible gap between the inside of one of the locking lugs and the rim of the container was observed.This is not considered a defect and further evaluation of the physical sample would be required to determine if the gasket height or start/stop position of the gasket was an issue.If the gasket start/stop position was located near the locking lug, it¿s possible that the customer would experience difficulty closing this lid.The exact root cause could not be determined from the video and photos provided.Based on the information available and the investigation findings, additional actions are deemed unnecessary at this time.If additional information or a physical sample is received warranting further analysis, the investigation will be resumed.This complaint will be used for tracking and trending purposes.

• Brand Name: 8 GA GASKETED SLIDE LID - RED
• Type of Device: CONTAINER, SHARPS
• Manufacturer (Section D): COVIDIEN; 815 tek drive; crystal lake IL 60039 9002
• MDR Report Key: 11095671
• MDR Text Key: 262192160
• Report Number: 1424643-2020-00590
• Device Sequence Number: 1
• Product Code: MMK
• UDI-Device Identifier: 30884521022526
• UDI-Public: 30884521022526
• 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,Followup
• Report Date: 02/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 8997S
• Device Catalogue Number: 8997S
• Device Lot Number: 20D04963
• Date Manufacturer Received: 12/15/2020
• Patient Sequence Number: 1