MAUDE Adverse Event Report: NIPRO (THAILAND) CORP., LTD. NIPRO SAFETOUCH PSV SCALP VEIN SET WITH SAFETY DEVICE; SAFETY SCALP VEIN SET

Model Number PSV-SF-21-ET

Device Problems Mechanical Problem (1384); Malposition of Device (2616)

Patient Problem Needle Stick/Puncture (2462)

Event Date 11/06/2017

Event Type  Injury  

Event Description

During disposal of the device, the nurse punctured her finger on right hand due to the safety mechanism not working properly (did not cover the needle completely, leaving it exposed).Medical intervention was required, but details were not provided by the user.Actual used device was disposed of by the user.

• Brand Name: NIPRO SAFETOUCH PSV SCALP VEIN SET WITH SAFETY DEVICE
• Type of Device: SAFETY SCALP VEIN SET
• Manufacturer (Section D): NIPRO (THAILAND) CORP., LTD.; 10/2 moo 8,; bangnomko, sena; ayuthaya, thailand, 13110 ; TH 13110
• Manufacturer (Section G): NIPRO (THAILAND) CORP., LTD.; 10/2 moo 8,; bangnomko, sena; ayuthaya, thailand, 13110 ; TH 13110
• Manufacturer Contact: michelle tejada ; 3150 nw 107 avenue; miami 33172 ; 3055997174
• MDR Report Key: 7050460
• MDR Text Key: 92715705
• Report Number: 8041145-2017-00012
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K140136
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 11/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2021
• Device Model Number: PSV-SF-21-ET
• Device Lot Number: 16L12
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/08/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/12/2016
• 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
• Patient Outcome(s): Other; Required Intervention