MAUDE Adverse Event Report: NIPRO (THAILAND) CORP. LTD. NIPRO AVF TULIP NEEDLE; AVF NEEDLE

Model Number FT+162530BC

Device Problem Device Handling Problem (3265)

Patient Problem Needle Stick/Puncture (2462)

Event Type  Injury  

Event Description

User facility reported that when removing the needle from the patient's access, the needle did not retract properly leaving needle exposed, causing a needle stick injury.No further information is available, no date of occurrence was recorded by the facility.Actual used sample was discarded by the user.

• Brand Name: NIPRO AVF TULIP NEEDLE
• Type of Device: AVF NEEDLE
• Manufacturer (Section D): NIPRO (THAILAND) CORP. LTD.; 10/2 moo 8, bangnomko, sena; ayuthaya,, 13110 ; TH 13110
• Manufacturer (Section G): NIPRO (THAILAND) CORP. LTD.; 10/2 moo 8, bangnomko, sena; ayuthaya,, 13110 ; TH 13110
• Manufacturer Contact: michelle tejada ; 3150 nw 107 avenue; miami, FL 33172 ; 3055997174
• MDR Report Key: 10646496
• MDR Text Key: 210369610
• Report Number: 8041145-2020-00012
• 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: distributor,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FT+162530BC
• Device Lot Number: 20C29K
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/19/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/29/2020
• 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