MAUDE Adverse Event Report: COVIDIEN SHARPS CONTAINER 12GAL RED; CONTAINER, SHARPS

Model Number	8932PG2
Medical Device Problem Code	Component or Accessory Incompatibility (2897)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/06/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complainant indicated that the sample is available to be returned but to date it 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 new substitute red sharps container in each theatre pose a safety risk.The lids do not properly fit on the red buckets and scrub nurses are unable to safely dispose of their sharps using the foot pedal as it does not lift the lid.Also there is no opening/hole in the lid to place small sharps.The end user must use their hands to lift the lid and risks a needle stick/sharp injury.In addition, they are unable to see how full the bin is prior to opening.The customer feels that this is not an appropriate safe substitute.There have been no injuries reported.
Additional Manufacturer Narrative
Section g3 (date received by manufacturer) has been corrected from 26-jul-2021 to 22-jul-2021.

• Brand Name: SHARPS CONTAINER 12GAL RED
• Common Device Name: CONTAINER, SHARPS
• Manufacturer (Section D): COVIDIEN; 815 tek drive; crystal lake IL 60039 9002
• MDR Report Key: 12242123
• Report Number: 1424643-2021-00613
• Device Sequence Number: 14492597
• Product Code: MMK
• UDI-Device Identifier: 40884521022417
• UDI-Public: 40884521022417
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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
• Report Date (Section B): 07/28/2021

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: 8932PG2
• Device Catalogue Number: 8932PG2
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/26/2021
• Supplement Date Received by Manufacturer: 07/26/2021
• Initial Report FDA Received Date: 07/28/2021
• Supplement Report FDA Received Date: 07/28/2021
• Patient Sequence Number: 1