MAUDE Adverse Event Report: NIPRO SAFETOUCH II NEEDLE; AVF NEEDLE

Model Number	FS+173230BC
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/13/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Numerous instances of safety device failing (failing to clip, failing to retract), no injuries are reported at this time.Facility has been trained and has been using the safetouch ii needles for over 5 years.No additional information provided.
Event or Problem Description
Numerous instances of safety device failing (failing to clip, failing to retract), no injuries are reported at this time.Facility has been trained and has been using the safetouch ii needles for over 5 years.No additional information provided.
Additional Manufacturer Narrative
Investigation report attached is on retained samples by manufacturer only.(b)(6) 2021: we attempted multiple times to try to obtain samples from the customer.On (b)(6) 2021, the customer returned samples to our factory for investigation, lot number was not identified, samples were not used on patients.See attached report.
Additional Manufacturer Narrative
Investigation report attached is on retained samples by manufacturer only.
Event or Problem Description
Numerous instances of safety device failing (failing to clip, failing to retract), no injuries are reported at this time.Facility has been trained and has been using the safetouch ii needles for over 5 years.No additional information provided.

• Brand Name: NIPRO SAFETOUCH II NEEDLE
• Common Device Name: AVF NEEDLE
• MDR Report Key: 11803653
• Report Number: 8041145-2021-00011
• Device Sequence Number: 19711685
• Product Code: FOZ
• UDI-Device Identifier: 00383790000208
• UDI-Public: 00383790000208
• Combination Product (Y/N): N
• Initial Reporter State: ME
• 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: distributor,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/08/2021

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+173230BC
• Device Catalogue Number: FS+173230BC
• Device Lot Number: 20D11
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2021
• Initial Date Received by Manufacturer: 04/21/2021
• Supplement Date Received by Manufacturer: 04/21/2021; 04/21/2021
• Initial Report FDA Received Date: 05/10/2021
• Supplement Report FDA Received Date: 08/04/2021; 09/08/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/11/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other