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

Model Number 8936PG2

Device Problem Separation Problem (4043)

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

Event Date 05/03/2021

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.

Event 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-
• Type of Device: CONTAINER, SHARPS
• Manufacturer (Section D): COVIDIEN; 815 tek drive; crystal lake IL 60039 9002
• Manufacturer (Section G): COVIDIEN; 815 tek drive; crystal lake IL 60039 9002
• Manufacturer Contact: jill saraiva ; 15 hampshire street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 11837769
• MDR Text Key: 251203199
• Report Number: 1424643-2021-00600
• Device Sequence Number: 1
• Product Code: MMK
• UDI-Device Identifier: 40884521022431
• UDI-Public: 40884521022431
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 8936PG2
• Device Catalogue Number: 8936PG2
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/05/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1