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

Model Number	8936PG2
Medical Device Problem Code	Separation Problem (4043)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/03/2021
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 the lid appears to snap down but then can lift straight up and does not contain the contents which is a safety hazard.No patient injury was reported.

• Brand Name: SHARPS CONTAINER 12GAL SLIDE-
• Common Device Name: CONTAINER, SHARPS
• Manufacturer (Section D): COVIDIEN; 815 tek drive; crystal lake IL 60039 9002
• MDR Report Key: 11837769
• Report Number: 1424643-2021-00600
• Device Sequence Number: 1086222
• Product Code: MMK
• UDI-Device Identifier: 40884521022431
• UDI-Public: 40884521022431
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/17/2021

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: 8936PG2
• Device Catalogue Number: 8936PG2
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/05/2021
• Initial Report FDA Received Date: 05/17/2021
• Patient Sequence Number: 1