MAUDE Adverse Event Report: NIPRO (THAILAND) CORP. LTD. NIPRO SAFETOUCH II AVF NEEDLE

Model Number	FS+152530BC
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Nurse manager, reported that a safetouch ii needle would not retract into the safety upon removal.Further information has been requested including what the affected lot# is.This was noticed upon removing the needle post treatment.No blood was lost, no adverse events occurred, no needle stick resulted.Additional details 10/22/2020: the treatment was completed, with no interruptions.No patient harm.At the end of the treatment when staff removed the needle from the patient access, they were unable to slide the safety over the needle: some would not move at all, my experience was that they were very difficult to move, causing the use of 2 hands, and dripping blood and saline in the process.Exact date of occurrence is unknown.Event occurred between september and october 2020.

• Brand Name: NIPRO SAFETOUCH II AVF NEEDLE
• Common Device Name: AVF NEEDLE
• Manufacturer (Section D): NIPRO (THAILAND) CORP. LTD.; 10/2 moo 8, bangnomko, sena; ayuthaya,, 13110 ; TH 13110
• MDR Report Key: 10808979
• Report Number: 1056186-2020-00015
• Device Sequence Number: 4141375
• Product Code: FOZ
• UDI-Device Identifier: 00383790000062
• UDI-Public: 00383790000062
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/09/2020
• Report Date (Section F): 11/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2024
• Device Model Number: FS+152530BC
• Device Catalogue Number: FS+152530BC
• Device Lot Number: 20A25
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/12/2020
• Device Age: 10 MO
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 11/09/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Date Report Sent to FDA: 11/09/2020