MAUDE Adverse Event Report: BAYER HEALTHCARE LLC MICROLET; LANCETS

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Needle Stick/Puncture (2462)

Event Date 12/27/2013

Event Type  Injury  

Event Description

A nurse in (b)(6) accidentally stuck herself with a used lancet that was wrapped in a tissue without the protective cap on it.The product information was not provided.No product is expected to be returned for evaluation.

Manufacturer Narrative

The product information was not provided.The manufacture date could not be determined and lancets are not 510(k) cleared.In some countries outside the us, customer information is not provided due to privacy laws.

• Brand Name: MICROLET
• Type of Device: LANCETS
• Manufacturer (Section D): BAYER HEALTHCARE LLC; 430 s. beiger st.; mishawaka IN 46544
• Manufacturer (Section G): BAYER HEALTHCARE LLC; 430 s. beiger st.; mishawaka IN 46544
• Manufacturer Contact: roger sonnenburg ; 430 w. beiger st.; mishawaka, IN 46544 ; 5742563441
• MDR Report Key: 3587622
• MDR Text Key: 4187878
• Report Number: 1826988-2014-00011
• Device Sequence Number: 1
• Product Code: FMK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Type of Report: Initial
• Report Date: 01/09/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Nurse
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/09/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1