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

Catalog Number NON134000

Device Problem Break (1069)

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

Event Date 09/10/2022

Event Type  malfunction  

Event Description

A new pill crusher was brought into the patient's room to crush pills for oral administration.Upon crushing the first medication, the pill crusher broke, and the bottom of the crusher had a piece of plastic that broke off and could have potentially been mixed with the medication.The pill was discarded and did not reach the patient, and the nurse set aside the pill crusher for further investigation if needed to see if more lots have been affected.

• Brand Name: MEDLINE PILL CRUSHER
• Type of Device: PILL CRUSHER, CUTTER
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; one medline place; mundelein IL 60060
• MDR Report Key: 15492173
• MDR Text Key: 300644401
• Report Number: 15492173
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: NON134000
• Device Lot Number: 50922040001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/21/2022
• Event Location: Hospital
• Date Report to Manufacturer: 09/27/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1