MAUDE Adverse Event Report: COVIDIEN UNKNOWN SHARPS DISPOSAL; CONTAINER, SHARPS

Model Number 8935Y

Device Problem Fail-Safe Problem (2936)

Patient Problem Insufficient Information (4580)

Event Date 04/21/2021

Event Type  malfunction  

Manufacturer Narrative

The product id and lot number were not provided.As a result, the udi could not be identified.The complainant indicated that it is unknown if the device will 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.  as part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product. if additional information or the sample is received, the investigation will be reopened and responded to accordingly.

Event Description

Customer reports: the new sharps container bucket lids are very difficult to "engage" on to the bucket.At first it seems that the lid "clicks" on but when lifting up on it the lid comes off with only a little tug.

Manufacturer Narrative

Updates made to the following fields as additional information was provided on 5/14/2021.D4: model number: 8935y, catalog number 8935y and udi# (b)(4).

• Brand Name: UNKNOWN SHARPS DISPOSAL
• Type of Device: CONTAINER, SHARPS
• Manufacturer (Section D): COVIDIEN; 815 tek drive; crystal lake IL 60039 9002
• MDR Report Key: 11772909
• MDR Text Key: 251368140
• Report Number: 1424643-2021-00598
• Device Sequence Number: 1
• Product Code: MMK
• 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: 05/14/2021

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
• Device Operator: No Information
• Device Model Number: 8935Y
• Device Catalogue Number: 8935Y
• Initial Date Manufacturer Received: 04/21/2021
• Initial Date FDA Received: 05/04/2021
• Supplement Dates Manufacturer Received: 04/21/2021
• Supplement Dates FDA Received: 05/14/2021
• Patient Sequence Number: 1