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

Model Number	FS+152530BC
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/21/2021
Type of Reportable Event	Malfunction
Event or Problem Description
During dialysis treatment the small clear plastic ring below the safety, had cracked and fell off.Treatment was completed and the nurse went to remove the avf fistula needle and noted it was sitting by the patients hand.No issue removing the avf needle.No injuries or medical interventions reported.
Event or Problem Description
During dialysis treatment the small clear plastic ring below the safety, had cracked and fell off.Treatment was completed and the nurse went to remove the avf fistula needle and noted it was sitting by the patients hand.No issue removing the avf needle.No injuries or medical interventions reported.

• 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: 11897875
• Report Number: 8041145-2021-00013
• Device Sequence Number: 11116121
• Product Code: FOZ
• UDI-Device Identifier: 00383790000062
• UDI-Public: 00383790000062
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: distributor,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/02/2021

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: 03/31/2025
• 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: 05/12/2021
• Initial Date Received by Manufacturer: 04/27/2021
• Supplement Date Received by Manufacturer: 04/27/2021
• Initial Report FDA Received Date: 05/27/2021
• Supplement Report FDA Received Date: 08/02/2021
• 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