MAUDE Adverse Event Report: OWEN MUMFORD USA, INC. UNISTIK; LANCET, BLOOD

Model Number 28 G 1.8 MM

Device Problems Detachment Of Device Component (1104); Scratched Material (3020)

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

Event Date 04/03/2017

Event Type  malfunction  

Event Description

When the safety gadget is removed from lancet, device falls apart, resulting in an open sharp.

• Brand Name: UNISTIK
• Type of Device: LANCET, BLOOD
• Manufacturer (Section D): OWEN MUMFORD USA, INC.; 1755 west oak commons ct.; marietta GA 30062
• MDR Report Key: 6507156
• MDR Text Key: 73255994
• Report Number: 6507156
• Device Sequence Number: 1
• Product Code: FMK
• 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: 04/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 28 G 1.8 MM
• Device Lot Number: 160821
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/04/2017
• Event Location: Hospital
• Date Report to Manufacturer: 04/04/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 77 YR
• Patient Weight: 155