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

Model Number 8932PG2

Device Problem Component or Accessory Incompatibility (2897)

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

Event Date 07/06/2021

Event Type  malfunction  

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 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.

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
• Type of Device: CONTAINER, SHARPS
• Manufacturer (Section D): COVIDIEN; 815 tek drive; crystal lake IL 60039 9002
• MDR Report Key: 12242123
• MDR Text Key: 263971224
• Report Number: 1424643-2021-00613
• 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: 07/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2021
• 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: 07/22/2021
• Patient Sequence Number: 1