MAUDE Adverse Event Report: INTERNATIONAL TECHNIDYNE CORP. ITC WHOLE BLOOD CONTROL; PLASMA, COAGULATION CONTROL

Model Number QCACT

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

Patient Problem Postoperative refraction, unexpected (2642)

Event Date 06/25/2014

Event Type  malfunction  

Event Description

Health professional reports end user injury while preparing the itc whole blood control.Health professional was adding diluent with a syringe to reconstitute the dried whole blood control material.When withdrawing the needle from the vial, health professional punctured her lateral palm of left hand with syringe.Health professional was wearing gloves at this time.The wound was cleansed with an antibacterial scrub.Itc whole blood control does not contain human blood products.

Manufacturer Narrative

This mdr submitted on (b)(4) 2014 references itc complaint case (b)(4).No ncmrs identified.No related complaint trends or capas identified.Itc has requested all data required for form 3500a.

• Brand Name: ITC WHOLE BLOOD CONTROL
• Type of Device: PLASMA, COAGULATION CONTROL
• Manufacturer (Section D): INTERNATIONAL TECHNIDYNE CORP.; edison NJ 08820
• Manufacturer Contact: eleanor fox ; 23 nevsky st.; edison, NJ 08820 ; 7325485700
• MDR Report Key: 3993985
• MDR Text Key: 4888678
• Report Number: 2250033-2014-00032
• Device Sequence Number: 1
• Product Code: GGN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K944691
• 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: 06/25/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2015
• Device Model Number: QCACT
• Device Catalogue Number: QCACT
• Device Lot Number: C4TCA007
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/25/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2014
• 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
• Patient Outcome(s): Other