MAUDE Adverse Event Report: HTL-STREFA S.A. ACTI-LANCE SAFETY LANCET UNIVERSAL 23G

Model Number	23G
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Codes	Pain (1994); Swelling/ Edema (4577)
Type of Reportable Event	Malfunction
Event or Problem Description
Lab reports a little difficulty with blood flow after using the lancet, but no pain.Patient then returned two days later, finger was red, swollen, and painful to touch.An x-ray revealed small object in skin of finger used.

• Brand Name: ACTI-LANCE SAFETY LANCET UNIVERSAL 23G
• Common Device Name: SAFETY LANCET
• Manufacturer (Section D): HTL-STREFA S.A.; adamowek 7; ozorkow, 95-03 5; PL 95-035
• Manufacturer (Section G): HTL-STREFA S.A.; adamowek 7; ozorkow, 95-03 5; PL 95-035
• Manufacturer Contact: justyna zemigala ; adamowek 7; ozorkow, 95-03-5 ; PL 95-035
• MDR Report Key: 14407069
• Report Number: 9613304-2022-00005
• Device Sequence Number: 16751571
• Product Code: FMK
• UDI-Device Identifier: 05901549097023
• UDI-Public: (01)05901549097023(17)251201(10)A11L866M1
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 05/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/01/2025
• Device Model Number: 23G
• Device Catalogue Number: 7156
• Device Lot Number: A11L866M1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/18/2022
• Initial Report FDA Received Date: 05/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/19/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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
• Patient Sex: Male