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

Model Number	FS+162530BCR
Medical Device Problem Codes	Break (1069); Material Separation (1562)
Health Effect - Clinical Codes	Bruise/Contusion (1754); Pain (1994); Skin Tears (2516)
Date of Event	04/16/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
After completion of dialysis treatment, the small "o" ring between the needle and the wings, broke off during needle removal.Staff did not notice and the patient's access was covered with a bandaid and taped.On the patient's next scheduled treatment, staff removed the tape and bandaid and found an indent / wound on the patient's access.Patient complained of pain.Staff found the small "o" ring stuck on the bandaid that was removed.No further information was provided.
Event or Problem Description
After completion of dialysis treatment, the small "o" ring between the needle and the wings, broke off during needle removal.Staff did not notice and the patient's access was covered with a bandaid and taped.On the patient's next scheduled treatment, staff removed the tape and bandaid and found an indent / wound on the patient's access.Patient complained of pain.Staff found the small "o" ring stuck on the bandaid that was removed.No further information was provided.

• 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: 10040533
• Report Number: 8041145-2020-00005
• Device Sequence Number: 14199782
• Product Code: FIE
• UDI-Device Identifier: 00383790000154
• UDI-Public: 00383790000154
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K063721
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2024
• Device Model Number: FS+162530BCR
• Device Catalogue Number: FS+163230BCR
• Device Lot Number: 19B21
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2020
• Initial Date Received by Manufacturer: 04/17/2020
• Supplement Date Received by Manufacturer: 04/17/2020
• Initial Report FDA Received Date: 05/08/2020
• Supplement Report FDA Received Date: 06/29/2020
• 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