MAUDE Adverse Event Report: INTERNATIONAL TECHNIDYNE CORP. HEMOCHRON CONTROL PLASMA NORMAL/ABNORMAL; PLASMA, COAGULATION CONTROL

Model Number QCACT

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

Patient Problem Laceration(s) (1946)

Event Date 06/08/2015

Event Type  malfunction  

Event Description

Healthcare professional reported that an end user sustained a needle stick while dispensing the product.A nurse was dispensing hemochron control plasma into a hemochron tube when the puncture injury occurred to the left index finger.The end user was wearing gloves at the time.The nurse sought medical attention and was evaluated by the employee health physician.No significant blood loss occurred.No complications or other related medical issues were reported.

Manufacturer Narrative

This mdr submitted on 06/23/2015 references (b)(4).Method: actual device not evaluated.Process evaluation was not performed as the complaint is not related to product performance or packaging.Result: no results available since no evaluation performed.Conclusion: human factors issue.Training deficiency.Device not returned.Itc has requested all data required for form 3500a.

• Brand Name: HEMOCHRON CONTROL PLASMA NORMAL/ABNORMAL
• Type of Device: PLASMA, COAGULATION CONTROL
• Manufacturer (Section D): INTERNATIONAL TECHNIDYNE CORP.; edison NJ 08820
• Manufacturer Contact: jon mcdermed ; 23 nevsky st.; edison, NJ 08820 ; 8582632490
• MDR Report Key: 4868081
• MDR Text Key: 20779122
• Report Number: 2250033-2015-00006
• Device Sequence Number: 1
• Product Code: GGN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K882480
• 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: 06/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 09/01/2015
• Device Model Number: QCACT
• Device Catalogue Number: QCACT
• Device Lot Number: K4TCA018
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/08/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2014
• 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