MAUDE Adverse Event Report: HTL-STREFA S.A. MEDLANCE PLUS LITE, 25G 1.5MM; FMK

Model Number 550

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Needle Stick/Puncture (2462)

Event Type  malfunction  

Manufacturer Narrative

For batch number w50k923d6 the date of manufacturing is 11/07/2016 to 11/16/2016.Sample of the defective product/sample from the customer - not available.Due to lack of availability of a defective product sample from a customer , it is not possible to make a thorough assessment and case analysis reported by the customer.The archival sample of lot no.W50k923d6 was tested for compliance with the parameters established in product specifications zn-2005/htl- 553-556.01 edition 13.All the lancets were correctly activated, made a puncture through a pad of 1,0 mm, imitating the minimum required penetration depth, and the needles retracted.There were no broken lancets or loose parts found in the trading box.There were no defects found in the archival sample, which could impact the possibility of emergence of defect (disintegrating lancet) - the defect was not confirmed in the archival sample.Medlance plus complaints have been reviewed since 2014 - this is the first such complaint.The event took place in europe ((b)(6)), but this serial number was also distributed in the united states.

Event Description

Safety lancet totally collapsed while using.Means it completely went into its pieces.A nurse was hurt and additionally got in contact with patient's blood.

• Brand Name: MEDLANCE PLUS LITE, 25G 1.5MM
• Type of Device: FMK
• Manufacturer (Section D): HTL-STREFA S.A.; adamowek 7; ozorkow, 95-03 5; PL 95-035
• Manufacturer Contact: aleksandra prazmowska-wilanowska ; adamowek 7; ozorkow, 95-03-5 ; PL 95-035 ; 22700016
• MDR Report Key: 6743272
• MDR Text Key: 81144698
• Report Number: 9613304-2017-00002
• Device Sequence Number: 1
• Product Code: FMK
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial
• Report Date: 07/24/2017

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 Operator: Nurse
• Device Expiration Date: 08/01/2021
• Device Model Number: 550
• Device Catalogue Number: 7043
• Device Lot Number: W50K923D6
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/28/2017
• Initial Date FDA Received: 07/26/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/16/2016
• 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