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

Model Number NON134000

Device Problem Break (1069)

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

Event Date 09/27/2022

Event Type  malfunction  

Event Description

We have had 4 medline pill crushers which have broken during use.The plastic bottoms have crushed ¿ lot# 50922050001 on 2 of them.The other 2 were already out of the boxes and in patient rooms so we don¿t have lot numbers for these.Manufacturer response for pill crusher, pill crusher (per site reporter) have already reported a similar incident.

• Brand Name: PILL CRUSHER
• Type of Device: PILL CRUSHER/CUTTER
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; one medline pl.; mundelein IL 60060
• MDR Report Key: 15804224
• MDR Text Key: 303712484
• Report Number: 15804224
• 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: 11/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: NON134000
• Device Lot Number: 50922050001
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/09/2022
• Event Location: Hospital
• Date Report to Manufacturer: 11/16/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1