MAUDE Adverse Event Report: INTERNATIONAL TECHNIDYNE CORP. DIRECTCHECK QUALITY CONTROL; PLASMA, COAGULATION CONTROL

Model Number DCJACT-N

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

Patient Problem Laceration(s) (1946)

Event Date 06/04/2015

Event Type  malfunction  

Event Description

Healthcare professional reported that an injury occurred to an end user who was preparing to discard a used directcheck quality control, which is packaged in a crushable vial.End user was wearing gloves.While removing the protective sleeve provided to safeguard against potential injury during use of the device, end user discovered crushed glass shards lodged in the sleeve.End user's right thumb was punctured by a shard of glass while attempting to remove it.End use washed their hands immediately and sought medical attention.No significant blood loss occurred.No complications or other related medical issues were reported.

Manufacturer Narrative

(b)(4).Process evaluation was not performed as the complaint is not related to product performance or packaging.

• Brand Name: DIRECTCHECK QUALITY CONTROL
• 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: 4844604
• MDR Text Key: 5946779
• Report Number: 2250033-2015-00005
• Device Sequence Number: 1
• Product Code: GGN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K120977
• 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: 06/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 08/01/2016
• Device Model Number: DCJACT-N
• Device Catalogue Number: DCJACT-N
• Device Lot Number: C5DNA007
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/04/2015
• Initial Date FDA Received: 06/11/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2015
• 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