MAUDE Adverse Event Report: APOTHECARY PRODUCTS, LLC. HEALTHSMART PILL CRUSHER; PILL CRUSHER/CUTTER

Device Problem Degraded (1153)

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

Event Type  No Answer Provided  

Event Description

When speaking with a group of nursing staff about our current practices of crushing medication tablets, in response to an (b)(4) newsletter about an issue with a plastic enteral syringe product, it was brought to my attention an issue with a different product we use for pill crushing.Currently, a product we carry is the healthsmart pill crusher/pulverizer.Several nurses have brought it to my attention that in the past, when using the product to crush tablets, the plastic bottom has shattered/broken while in use.This could have led to small pieces of plastic being administered to patients if nursing staff was not careful.We are currently in the process of removing these products from all of our units to prevent any breakages in the future.We will instead utilize our other product, silent knight, in the future.(b)(4).

• Brand Name: HEALTHSMART PILL CRUSHER
• Type of Device: PILL CRUSHER/CUTTER
• Manufacturer (Section D): APOTHECARY PRODUCTS, LLC.
• MDR Report Key: 10250588
• MDR Text Key: 198388909
• Report Number: MW5095448
• 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: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 07/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1