MAUDE Adverse Event Report: BRIGGS MEDICAL SERVICE CO. (BRIGGS HEALTHCARE) HEALTHSMART; PILL CRUSHER/CUTTER

Lot Number 921-6439-0000

Device Problems Break (1069); Detachment Of Device Component (1104); Device Contamination with Chemical or Other Material (2944)

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

Event Date 10/23/2017

Event Type  malfunction  

Event Description

Shards from the bottle (rims for screw top) broke of in the container for one incident.Sheds of red top were in the container for the second incident.

• Brand Name: HEALTHSMART
• Type of Device: PILL CRUSHER/CUTTER
• Manufacturer (Section D): BRIGGS MEDICAL SERVICE CO. (BRIGGS HEALTHCARE); 1931 norman dr; waukegan IL 60085
• MDR Report Key: 6986685
• MDR Text Key: 90693705
• Report Number: 6986685
• 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: 10/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: 921-6439-0000
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/24/2017
• Event Location: Hospital
• Date Report to Manufacturer: 10/24/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1