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

Model Number	FS+173230BC
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
We received a complaint from our customer stating they recently ( (b)(6) 2020) heard from multiple customers stating the safety device will not release leaving the needle exposed.They are not sure how many of these needles were defective because some staff members did not report it, however, about 10 on the initial date of incident.There were no injuries, but we pulled the needles from production to prevent any, as well.Staff could not pinch the safety device or retract the needle.The safety would not disengage, the needles had to be removed without pulling them back into the safety sheath.Exact date of occurrence is unknown.Actual used samples were discarded.
Event or Problem Description
We received a complaint from our customer stating they recently (august 2020) heard from multiple customers stating the safety device will not release leaving the needle exposed.They are not sure how many of these needles were defective because some staff members did not report it, however, about 10 on the initial date of incident.There were no injuries, but we pulled the needles from production to prevent any, as well.Staff could not pinch the safety device or retract the needle.The safety would not disengage, the needles had to be removed without pulling them back into the safety sheath.Exact date of occurrence is unknown.Actual used samples were discarded.

• 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: 10809559
• Report Number: 8041145-2020-00017
• Device Sequence Number: 3500675
• Product Code: FOZ
• UDI-Device Identifier: 00383790000208
• UDI-Public: 00383790000208
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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): 12/06/2020

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: 11/30/2024
• Device Model Number: FS+173230BC
• Device Catalogue Number: FS+173230BC
• Device Lot Number: 19L02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2020
• Initial Date Received by Manufacturer: 10/13/2020
• Supplement Date Received by Manufacturer: 10/13/2020
• Initial Report FDA Received Date: 11/09/2020
• Supplement Report FDA Received Date: 12/06/2020
• 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