MAUDE Adverse Event Report: KAKOGAWA FACTORY CA-1500; CA-1500 AUTOMATED COAGULATION ANALYZER,

Model Number CA-1500

Device Problem Use of Device Problem (1670)

Patient Problem Needle Stick/Puncture (2462)

Event Date 11/11/2022

Event Type  Injury  

Manufacturer Narrative

The ca-1500 operator manual warns the user: "handle the piercer with care.The tip of the piercer is sharp.If it touches your hands or fingers, you may be injured or be infected.Be careful especially when replacing." root cause is accidental contact with the piercer.No analyzer deficiency was identified.

Event Description

A service engineer in italy experienced a piercer injury to the finger while servicing the analyzer.While he was closing the cover on the bottom of the instrument, the service engineer accidentally bumped against the piercer guide.The analyzer was not in use at the time of the event.The service engineer went to the emergency room (er) and had the cut disinfected by the medical staff.Additionally, the se received a tetanus injection within 24 hours following the er's instructions.There was no harm reported to the se from the tetanus injection.This event is reportable to the fda based on an adverse event.

• Brand Name: CA-1500
• Type of Device: CA-1500 AUTOMATED COAGULATION ANALYZER,
• Manufacturer (Section D): KAKOGAWA FACTORY; 314-2 kitano; noguchi-cho, kakogawa, hyogo 675-0 011; JA 675-0011
• Manufacturer (Section G): KAKOGAWA FACTORY; 314-2 kitano; noguchi-cho, kakogawa, hyogo 675-0 011; JA 675-0011
• Manufacturer Contact: william haste ; 577 aptakisic rd; lincolnshire, IL 60069 ; 2245439459
• MDR Report Key: 15958215
• MDR Text Key: 305242550
• Report Number: 1000515253-2022-00012
• Device Sequence Number: 1
• Product Code: JPA
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K011235
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: CA-1500
• Device Catalogue Number: 97347516
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/16/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/10/2004
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other