MAUDE Adverse Event Report: COVIDIEN 2 GAL CONTAINER, RED; CONTAINER, SHARPS

Model Number	31142222
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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.
Event or Problem Description
The customer reported that when the sharps containers are autoclaved at level 3, the needles stick out of the container afterwards due to pressure.There was no injury reported.
Additional Manufacturer Narrative
A device history record review could not be performed because a lot number was not received with the complaint.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to the release of product.A lot will not be released without meeting all criteria.A physical sample was not received for evaluation.However, one photo was provided.The photo was visually analyzed and showed a needle penetrating the lid of a container (it is presumed to have been autoclaved).The containers are suitable for autoclave per the instructions for use and are designed to withstand up to 3.4 lbf of force by a needle in accordance with standards.The label indicates the maximum height the container may be safely filled to.In-process controls are in-place to ensure the label placement is accurate.Overfilling the container during autoclaving can lead to the condition reported.Based on the information available and the investigation findings, a corrective action is not applicable at this time.Functional testing and visual inspections are being performed according to our current quality standards and inspection procedures.If additional information is received warranting further analysis, the investigation will be resumed.This complaint will be used for tracking and trending purposes.

• Brand Name: 2 GAL CONTAINER, RED
• Common Device Name: CONTAINER, SHARPS
• Manufacturer (Section D): COVIDIEN; 815 tek drive; crystal lake IL 60039 9002
• MDR Report Key: 11066209
• Report Number: 1424643-2020-00589
• Device Sequence Number: 2560314
• Product Code: MMK
• UDI-Device Identifier: 40884521023100
• UDI-Public: 40884521023100
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/10/2021

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: 31142222
• Device Catalogue Number: 31142222
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/17/2020
• Supplement Date Received by Manufacturer: 12/17/2020
• Initial Report FDA Received Date: 12/23/2020
• Supplement Report FDA Received Date: 02/10/2021
• Patient Sequence Number: 1