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

Model Number FT+152530BC

Device Problem Device Handling Problem (3265)

Patient Problem Needle Stick/Puncture (2462)

Event Type  malfunction  

Event Description

Safety device opened during needle retraction exposing the needle and a staff member sustained a needle stick.No further details provided, unknown date of occurrence, actual used sample discarded.

• 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
• MDR Report Key: 10648663
• MDR Text Key: 210426170
• Report Number: 1056186-2020-00013
• Device Sequence Number: 1
• Product Code: MPB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FT+152530BC
• Device Lot Number: 20B19E
• 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: 10/08/2020
• Distributor Facility Aware Date: 09/18/2020
• Device Age: 7 MO
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 10/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other