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

Model Number 8507SA

Device Problem Defective Component (2292)

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

Event Date 12/09/2020

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 sharps container lids are not engaging properly and keep popping back up.It looks like the lids or the container are slightly warped.The lids would snap in fine on one side, but pop back up on the other.There was no harm to patients or staff.

• Brand Name: CONTAINER SHARPS 5QT RED
• 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: 11028577
• MDR Text Key: 222072019
• Report Number: 1424643-2020-00588
• Device Sequence Number: 1
• Product Code: MMK
• UDI-Device Identifier: 10884521023284
• UDI-Public: 10884521023284
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/17/2020

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
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 12/09/2020
• Initial Date FDA Received: 12/17/2020
• Type of Device Usage: N
• Patient Sequence Number: 1