MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. MEDLINE PILL CRUSHER; PILL CRUSHER/CUTTER

Model Number NON134000CS

Device Problem Break (1069)

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

Event Date 12/28/2021

Event Type  malfunction  

Event Description

Pill crusher being used and bottom broke out.Risk for cut.

• Brand Name: MEDLINE PILL CRUSHER
• Type of Device: PILL CRUSHER/CUTTER
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; 1 medline place; mundelein IL 60060
• MDR Report Key: 13235733
• MDR Text Key: 283673706
• Report Number: 13235733
• Device Sequence Number: 1
• Product Code: OHY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NON134000CS
• Device Catalogue Number: NON134000CS
• Device Lot Number: 91121080001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/28/2021
• Event Location: Hospital
• Date Report to Manufacturer: 01/12/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1