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

Model Number	8997S
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/15/2020
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
The customer reported that the lid does not fit well.There was no patient or staff harm.
Additional Manufacturer Narrative
E1 initial reporter name, email address, and phone number was corrected.
Additional 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
• Common Device Name: CONTAINER, SHARPS
• Manufacturer (Section D): COVIDIEN; 815 tek drive; crystal lake IL 60039 9002
• MDR Report Key: 11095671
• Report Number: 1424643-2020-00590
• Device Sequence Number: 17068911
• Product Code: MMK
• UDI-Device Identifier: 30884521022526
• UDI-Public: 30884521022526
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/19/2021

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
• Operator of Device: No Information
• Device Model Number: 8997S
• Device Catalogue Number: 8997S
• Device Lot Number: 20D04963
• Initial Date Received by Manufacturer: 12/15/2020
• Supplement Date Received by Manufacturer: 12/15/2020; 12/15/2020
• Initial Report FDA Received Date: 12/30/2020
• Supplement Report FDA Received Date: 01/05/2021; 02/19/2021
• Patient Sequence Number: 1