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

Model Number 8932PG2

Device Problems Component or Accessory Incompatibility (2897); Fail-Safe Problem (2936)

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

Event Date 06/04/2021

Event Type  malfunction  

Manufacturer Narrative

The complainant indicated that the device will not be returned for evaluation; therefore, a failure analysis is not available, and we are not able to determine the relationship between this device and the cause for this event.  if additional information or the sample is received, the investigation will be reopened and responded to accordingly.

Event Description

The customer reported that the lids do not fit properly and the opening does not keep sharps in.The surgeon was disposing his sharps and other sharps flipped up and out of the box.No one was injured.

Manufacturer Narrative

Section e1 has been updated to include the facility's address: (b)(6).

• Brand Name: SHARPS CONTAINER 12GAL RED
• Type of Device: CONTAINER, SHARPS
• Manufacturer (Section D): COVIDIEN; 815 tek drive; crystal lake IL 60039 9002
• MDR Report Key: 12103742
• MDR Text Key: 262200461
• Report Number: 1424643-2021-00608
• Device Sequence Number: 1
• Product Code: MMK
• UDI-Device Identifier: 40884521022417
• UDI-Public: 40884521022417
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 8932PG2
• Device Catalogue Number: 8932PG2
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/16/2021
• Patient Sequence Number: 1