MAUDE Adverse Event Report: HTL-STREFA S.A. MEDLANCE PLUS, SAFETY LANCET UNIVERSAL, 21G 1.8MM

Model Number	21G 1.8MM
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Type of Reportable Event	Malfunction
Event or Problem Description
After using the safety lancet to take capillary blood, it falls apart.The sharp needle, which is normally secured by the lancet inside, falls out.During disposal by the employee pricked herself with this needle.
Additional Manufacturer Narrative
The event fulfils the definition of serious incident according to mdr and will be reported to the ca in germany.This medical device is marked in usa.Therefore, as per cfr § 803.50(a), the event that occurred in the foreign country (in this case it is eu country) should be also reported to usa.

• Brand Name: MEDLANCE PLUS, SAFETY LANCET UNIVERSAL, 21G 1.8MM
• 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: 13976954
• Report Number: 9613304-2022-00002
• Device Sequence Number: 4961256
• Product Code: FMK
• UDI-Device Identifier: 05907506237112
• UDI-Public: (01)05907506237112(17)251001(10)A29G76H7
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/01/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/01/2025
• Device Model Number: 21G 1.8MM
• Device Catalogue Number: 7044
• Device Lot Number: A29G76H7
• 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: 01/25/2022
• Initial Report FDA Received Date: 04/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/29/2020
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown