MAUDE Adverse Event Report: LP ITALIANA SPA SEDIPLAST AUTOZERO WESTERGREN ESR SYSTEM

Model Number NP

Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)

Patient Problem Exposure to Body Fluids (1745)

Event Date 10/03/2014

Event Type  malfunction  

Event Description

Polymedco received a customer call stating that while one of their lab techs was inserting a sediplast pipette into the blood filled vial, the top of the pipette popped off and blood sprayed out.The lab tech was not wearing any facial personal protective equipment or using a lab shield.The lab tech was sprayed in the face with blood, sent to the emergency room for a bodily fluid exposure workup and released.(b)(4).

Manufacturer Narrative

A (b)(4) sediplast pipettes were distributed in the us market in 2014 ytd and there were no other incidents of this nature.In 2013, a safety alert went out highlighting the instructions for use.The instructions for use state that it is important to carefully and gently insert the pipette into the blood filled vial, without holding or blocking the top of the pipette.From 2013-2014 ytd, (b)(4) sediplast pipettes were distributed.An investigation is currently underway to document the probable root cause of the incident and assess if there is any necessary corrective action or safety alert required.

• Brand Name: SEDIPLAST AUTOZERO WESTERGREN ESR SYSTEM
• Type of Device: SEDIPLAST
• Manufacturer (Section D): LP ITALIANA SPA; via c. reale, 15/4 - 20157; milano ; IT
• Manufacturer Contact: 510 furnace dock rd.; cortlandt manor, NY 10567 ; 8004312123
• MDR Report Key: 4308389
• MDR Text Key: 19587939
• Report Number: 2435505-2014-00001
• Device Sequence Number: 1
• Product Code: JPH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: Company Representative,Distributor
• Reporter Occupation: Other
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 10/15/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2015
• Device Model Number: NP
• Device Catalogue Number: S-1000
• Device Lot Number: T0310A
• Other Device ID Number: NP
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 10/15/2014
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/15/2014
• Distributor Facility Aware Date: 10/03/2014
• Device Age: 5 MO
• Event Location: Other
• Date Report to Manufacturer: 10/15/2014
• Date Manufacturer Received: 10/03/2014
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other