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

Model Number 21G 1.8MM

Device Problem Material Separation (1562)

Patient Problem Needle Stick/Puncture (2462)

Event Type  malfunction  

Event 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.

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
• Type of Device: 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
• MDR Text Key: 298236761
• Report Number: 9613304-2022-00002
• Device Sequence Number: 1
• Product Code: FMK
• UDI-Device Identifier: 05907506237112
• UDI-Public: (01)05907506237112(17)251001(10)A29G76H7
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• 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
• Date Manufacturer Received: 01/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/29/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1