MAUDE Adverse Event Report: INTERNATIONAL TECHNIDYNE CORP. TENDERFOOT HEEL INCISION DEVICE; DEVICE, BLEEDING TIME

Model Number TF50I

Device Problem Insufficient Information (3190)

Patient Problem Needle Stick/Puncture (2462)

Event Date 05/19/2014

Event Type  malfunction  

Event Description

Distributor reports end user was injured during use of the tenderfoot.The tenderfoot device fell apart in the users hand after the device was used on the patient.The nurse sustained a puncture to the left pointer finger.The hospital's needle stick injury procedure was followed, including reporting and blood specimen testing.At this time, no subsequent adverse events associated with this event have been reported to itc.This event occurred outside of the united states.

Manufacturer Narrative

This mdr submitted (b)(4) 2014, references itc complaint case (b)(4).Patient code: the end user reported experienced a needle stick/puncture.Device code: no information device has been returned to manufacturer an is currently undergoing evaluation.Method code: no testing methods performed.Device has been returned to manufacturer and is currently undergoing evaluation.Result code: results pending completion of evaluation.Conclusion code: conclusion not yet available-evaluation in progress.

• Brand Name: TENDERFOOT HEEL INCISION DEVICE
• Type of Device: DEVICE, BLEEDING TIME
• Manufacturer (Section D): INTERNATIONAL TECHNIDYNE CORP.; edison NJ 08820
• Manufacturer (Section G): INTERNATIONAL TECHNIDYNE CORP.; 23 nevsky st.; edison NJ 08820
• Manufacturer Contact: eleanor fox ; 23 nevsky st.; edison, NJ 08820 ; 7325485700
• MDR Report Key: 3966516
• MDR Text Key: 4755727
• Report Number: 2250033-2014-00004
• Device Sequence Number: 1
• Product Code: JCA
• Combination Product (y/n): N
• PMA/PMN Number: K883968
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 05/27/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2017
• Device Model Number: TF50I
• Device Catalogue Number: TF50I
• Device Lot Number: BC309M
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/10/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/27/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/01/2013
• 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