MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; LANCET,SAFETY,21G,1.8MM,PUSH BUTTON

Catalog Number	MPHSFTY21Z
Medical Device Problem Code	Protective Measures Problem (3015)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	03/21/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Needle stick requiring treatment.
Additional Manufacturer Narrative
According to the customer contact, an employee used a safety lancet on a patient.After using the lancet, it was placed on a table, upon retrieving the device, it was reported that the needle was exposed and when picked up "punctured" the employee.According to the customer, policy requires the use of antiretroviral medication for the reported incident.The customer reports the employee is still under treatment of the medication.A sample was requested to be returned for evaluation.It has been determined that the reported event caused or contributed to serious injury, therefore, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

• Common Device Name: LANCET,SAFETY,21G,1.8MM,PUSH BUTTON
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: kelly zampella ; three lakes drive; northfield, IL 60093
• MDR Report Key: 16761154
• Report Number: 1417592-2023-00169
• Device Sequence Number: 19598507
• Product Code: FMK
• UDI-Device Identifier: 10193489006421
• UDI-Public: 10193489006421
• Combination Product (Y/N): N
• Initial Reporter State: PR
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Catalogue Number: MPHSFTY21Z
• Device Lot Number: 84620060004
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/22/2023
• Initial Report FDA Received Date: 04/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown