MAUDE Adverse Event Report: CARDINAL HEALTH 200, LLC SAFETY LANCET; SINGLE USE ONLY BLOOD LANCET WITH AN INTEGRAL SHARPS INJURY PREVENTION FEATURE

Model Number 2027-07-28

Device Problems Device Contamination with Body Fluid (2317); Fail-Safe Did Not Operate (4046)

Patient Problems Exposure to Body Fluids (1745); Needle Stick/Puncture (2462)

Event Date 06/05/2023

Event Type  malfunction  

Event Description

Needle did not retract and safety lock after finger stick, resulting in registered nurse (rn) getting stuck with dirty needle.

• Brand Name: SAFETY LANCET
• Type of Device: SINGLE USE ONLY BLOOD LANCET WITH AN INTEGRAL SHARPS INJURY PREVENTION FEATURE
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC; 3651 birchwood drive; waukegan IL 60085
• MDR Report Key: 17208300
• MDR Text Key: 317935168
• Report Number: 17208300
• Device Sequence Number: 1
• Product Code: FMK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2027-07-28
• Device Lot Number: 05919
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/07/2023
• Event Location: Hospital
• Date Report to Manufacturer: 06/27/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 17885 DA
• Patient Sex: Male
• Patient Weight: 44 KG