MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC MEDICHOICE MULTIPURPOSE PILL CRUSHER/SPLITTER; PILL CRUSHER/CUTTER

Catalog Number PLC1220

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

In attempts to split an uncoated round medication pill into equal halves, the device crushes the pill rendering it unusable as dose cannot safely be determined.Splitting a coated pill is a little better but still results in multiple chunks vs the desired 2 pieces.

• Brand Name: MEDICHOICE MULTIPURPOSE PILL CRUSHER/SPLITTER
• Type of Device: PILL CRUSHER/CUTTER
• Manufacturer (Section D): MEDLINE INDUSTRIES INC; one medline place; mundelein IL 60060
• MDR Report Key: 5093865
• MDR Text Key: 26424765
• Report Number: 5093865
• Device Sequence Number: 1
• Product Code: OHY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Nurse
• Device Catalogue Number: PLC1220
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/16/2015
• Device Age: 1 MO
• Event Location: Hospital
• Date Report to Manufacturer: 09/16/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1