MAUDE Adverse Event Report: FACET TECHNOLOGIES, LLC ACCU CHEK SAFE T PRO; LANCET, BLOOD

Catalog Number 3448622

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/04/2015

Event Type  malfunction  

Event Description

The patient care technician (pct) was going to do a blood sugar on a patient.When she reached into the cart to grab the lancet, she noticed the lancet was faulty.There was metal hanging outside of the lancet as if the spring was broken with metal exposed.There was no harm to the pct or patient.The lancet was removed from patient care and not used.

• Brand Name: ACCU CHEK SAFE T PRO
• Type of Device: LANCET, BLOOD
• Manufacturer (Section D): FACET TECHNOLOGIES, LLC; 101 liberty industrial parkway; mc donough GA 30253
• MDR Report Key: 4619875
• MDR Text Key: 5655912
• Report Number: 4619875
• Device Sequence Number: 1
• Product Code: FMK
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Invalid Data
• Device Catalogue Number: 3448622
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/06/2015
• Event Location: Hospital
• Date Report to Manufacturer: 03/20/2015
• Patient Sequence Number: 1