MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP-NORTHFIELD MEDLINE BIOHAZARD CONTAINER 5.4 QT; CONTAINER, SPECIMEN MAILER AND STORAGE, NON-STERILE

Model Number MD5705253

Device Problem Fail-Safe Problem (2936)

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

Event Date 04/27/2023

Event Type  malfunction  

Event Description

Containers prevent sharps products from fully falling into the container.This leads to sharps devices sticking out creating a potential needlestick hazard.

• Brand Name: MEDLINE BIOHAZARD CONTAINER 5.4 QT
• Type of Device: CONTAINER, SPECIMEN MAILER AND STORAGE, NON-STERILE
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP-NORTHFIELD
• MDR Report Key: 16854059
• MDR Text Key: 314484854
• Report Number: MW5117193
• Device Sequence Number: 1
• Product Code: NNK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MD5705253
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1