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

Model Number DCJCPT-A

Device Problem Use of Device Problem (1670)

Patient Problem Laceration(s) (1946)

Event Date 03/05/2015

Event Type  malfunction  

Event Description

Healthcare professional reported an injury to an end user that happened during reconstruction of a directcheck hemochron jr.Abnormal control packaged in a crushable vial.End user was wearing gloves but did not use the protective sleeve provided to safeguard against possible injury when reconstituting the product.End user sustained a cut to the thumb, which was washed with soap and water, sanitized with alcohol and covered with a sterile bandage.End user did not seek further medical attention; hospital policy only applies to needle sticks.Per policy, the decision whether or not to seek further medical attention was left to the end user.No significant blood loss occurred.Per follow-up communication, the puncture wound healed and the end user returned to work.There were no complications or other related medical issues.

Manufacturer Narrative

(b)(4).Method - actual device not evaluated.Dhr review was not performed as the complaint is unrelated to product performance or packaging.Product was not inspected or tested because the end user did not use the protective sleeve as indicated in the apckage insert.Results - no results available since no evaluation performed.Conclusion: human factors issue.Training deficiency.Review of this case determined that the end user had not been fully trained on the proper method to reconstitute the directcheck pt abnormal control vial.Protective sheath provide as a safeguard against possible injury was not utilized by the end user.Itc has requested all data required for form 3500a.

• Brand Name: DIRECTCHECK QUALITY CONTROL
• Type of Device: PLASMA, COAGULATION CONTROL
• Manufacturer (Section D): INTERNATIONAL TECHNIDYNE CORP.; edison NJ 08820
• Manufacturer Contact: jon mcdermed ; 8 olsen ave.; edison, NJ 08820 ; 8582632490
• MDR Report Key: 4620276
• MDR Text Key: 5695564
• Report Number: 2250033-2015-00002
• 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,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/05/2015

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: Health Professional
• Device Expiration Date: 11/01/2015
• Device Model Number: DCJCPT-A
• Device Catalogue Number: DCJCPT-A
• Device Lot Number: F4DAC004
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/05/2015
• Initial Date FDA Received: 03/18/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2014
• 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