MAUDE Adverse Event Report: COVIDIEN 7 GA SHARPS CONTAINER; CONTAINER, SHARPS

Model Number 31156550

Device Problems Component Incompatible (1108); Material Deformation (2976)

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 containers do not sit flush on a surface.Additional information was received from the customer that when sealing the sharps for proper disposal, the latches that keep the lid locked are not secure and re-open.Also, the sharps do not have a flat bottom where the sharps can sit flush to the table, desk or computer cart.When that happens it tends to get moved around leading to tipping over.If the sharps are full enough, it has caused a spillage of used sharps.

• Brand Name: 7 GA SHARPS CONTAINER
• 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: 9873907
• MDR Text Key: 195256553
• Report Number: 1424643-2020-00573
• Device Sequence Number: 1
• Product Code: MMK
• UDI-Device Identifier: 30884521042838
• UDI-Public: 30884521042838
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/24/2020

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: 31156550
• Device Catalogue Number: 31156550
• Device Lot Number: 255029
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 03/02/2020
• Initial Date FDA Received: 03/24/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1