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)
Date of Event	11/24/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Safetouch ii needle would not retract into the safety upon removal.This was noticed upon removing the needle post treatment.No blood was lost, no adverse events occurred, no needle stick resulted.(2 total incidents).This facility has used safetouch ii since (b)(6) 2019.The clinical specialist provided training on wednesday, (b)(6) 2019, wednesday, (b)(6) 2019, and wednesday, (b)(6) 2020 to provide supplemental training and support.
Event or Problem Description
Safetouch ii needle would not retract into the safety upon removal.This was noticed upon removing the needle post treatment.No blood was lost, no adverse events occurred, no needle stick resulted.(2 total incidents) this facility has used safetouch ii since (b)(6) 2019.The clinical specialist provided training on wednesday, (b)(6) 2019, wednesday, (b)(6) 2019, and wednesday, (b)(6) 2020 to provide supplemental training and support.

• 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: 11070481
• Report Number: 8041145-2020-00022
• Device Sequence Number: 11652884
• Product Code: FOZ
• UDI-Device Identifier: 00383790000062
• UDI-Public: 00383790000062
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K032777
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/31/2021

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: 20D16
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2020
• Initial Date Received by Manufacturer: 11/30/2020
• Supplement Date Received by Manufacturer: 11/30/2020
• Initial Report FDA Received Date: 12/23/2020
• Supplement Report FDA Received Date: 03/31/2021
• 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