MAUDE Adverse Event Report: NIPRO THAILAND CORPORATION LTD. NIPRO SAFETOUCH TULIP SAFETY AVF NEEDLE

Model Number FT+152530BC

Device Problems Improper or Incorrect Procedure or Method (2017); Device Handling Problem (3265)

Patient Problem Laceration(s) (1946)

Event Date 03/25/2014

Event Type  Injury  

Event Description

The clinician was disconnecting the avf needle from the blood tubing line and the connection was very tight causing the clinician to cut the palm of their hand.The clinician then went to the er and labs were drawn for cross-contamination.

Manufacturer Narrative

Device was not returned to manufacturer.

• Brand Name: NIPRO SAFETOUCH TULIP SAFETY AVF NEEDLE
• Type of Device: SAFETY AVF NEEDLE
• Manufacturer (Section D): NIPRO THAILAND CORPORATION LTD.; 10/2 moo 8, bangnomko, sena; phra nakhon si; ayutthaya, 13110 ; TH 13110
• Manufacturer (Section G): NIPRO THAILAND CORPORATION LTD.; 10/2 moo 8, bangnomko, sena; phra nakhon si; ayutthaya, 1311 0; TH 13110
• Manufacturer Contact: jessica oswald-mcleod ; 3150 nw 107th ave.; doral, FL 33172 ; 3055997174
• MDR Report Key: 3773958
• MDR Text Key: 4358159
• Report Number: 8041145-2014-00002
• Device Sequence Number: 1
• Product Code: MPB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K071145
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/25/2014,03/28/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2018
• Device Model Number: FT+152530BC
• Device Lot Number: 13I17
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/25/2014
• Distributor Facility Aware Date: 03/28/2014
• Device Age: 8 MO
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 03/28/2014
• Date Manufacturer Received: 03/28/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/17/2013
• 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
• Patient Outcome(s): Hospitalization