MAUDE Adverse Event Report: COVIDIEN CONTAINER SHARPS 5QT RED; CONTAINER, SHARPS

Model Number 8507SA

Device Problem Component Incompatible (1108)

Patient Problem No Consequences Or Impact To Patient (2199)

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. 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 lids do not fit the sharps containers.

Manufacturer Narrative

Please disregard this report number 1424643-2020-00575 after receipt of the sample from the customer, the investigation determined that cardinal health is not the manufacturer of the device.This report was submitted in error as the incident reported by the customer does not meet the mdr regulation requirements of a reportable event, as we are not the legal manufacturer for this particular device.

• Brand Name: CONTAINER SHARPS 5QT RED
• Type of Device: CONTAINER, SHARPS
• Manufacturer (Section D): COVIDIEN; 815 tek drive; crystal lake IL 60039 9002
• MDR Report Key: 9981918
• MDR Text Key: 195256032
• Report Number: 1424643-2020-00575
• Device Sequence Number: 1
• Product Code: MMK
• UDI-Device Identifier: 10884521023284
• UDI-Public: 10884521023284
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 05/14/2020

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
• Device Operator: No Information
• Device Model Number: 8507SA
• Device Catalogue Number: 8507SA
• Device Lot Number: 20A01163
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 04/16/2020
• Initial Date FDA Received: 04/21/2020
• Supplement Dates Manufacturer Received: 04/16/2020
• Supplement Dates FDA Received: 05/14/2020
• Patient Sequence Number: 1