MAUDE Adverse Event Report: APOTHECARY PRODUCTS LLC. HEALTHSMART PILL CRUSHER

Model Number	PC12
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	Not Applicable (3189)
Type of Reportable Event	Malfunction
Event or Problem Description
Apothecary products llc.Received a report from medwatch (report number mw5095448 [mdr report key (b)(4)]) : 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
• Common Device Name: PILL CRUSHER
• Manufacturer (Section D): APOTHECARY PRODUCTS LLC.; 11750 12th avenue south; burnsville, mn
• MDR Report Key: 10479652
• Report Number: 0002183416-2020-00004
• Device Sequence Number: 4284314
• Product Code: OHY
• UDI-Device Identifier: 00079573009161
• UDI-Public: 00079573009161
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 09/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: PC12
• Device Catalogue Number: PC12
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/04/2020
• Initial Report FDA Received Date: 09/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1