MAUDE Adverse Event Report: COVIDIEN CONTAINER SHARPS RED SLIDE LID DISP 18GL; CONTAINER, SHARPS

Model Number 8938

Device Problem Crack (1135)

Patient Problem Insufficient Information (4580)

Event Date 04/28/2021

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

Customer reports: the containers are cracked and cannot be used.

• Brand Name: CONTAINER SHARPS RED SLIDE LID DISP 18GL
• 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: 11752450
• MDR Text Key: 251415792
• Report Number: 1424643-2021-00597
• Device Sequence Number: 1
• Product Code: MMK
• UDI-Device Identifier: 40884521022233
• UDI-Public: 40884521022233
• 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: 04/30/2021

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: 8938
• Device Catalogue Number: 8938
• Device Lot Number: 20L10163
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 04/28/2021
• Initial Date FDA Received: 04/30/2021
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1