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

Model Number FS+162530BCR

Device Problems Break (1069); Material Separation (1562)

Patient Problems Bruise/Contusion (1754); Pain (1994); Skin Tears (2516)

Event Date 04/16/2020

Event Type  Injury  

Event 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 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
• Type of Device: AVF NEEDLE
• Manufacturer (Section D): NIPRO (THAILAND) CORP. LTD.; 10/2 moo 8, bangnomko, sena; ayuthaya,, 13110 ; TH 13110
• MDR Report Key: 10040533
• MDR Text Key: 190494761
• Report Number: 8041145-2020-00005
• Device Sequence Number: 1
• Product Code: FIE
• UDI-Device Identifier: 00383790000154
• UDI-Public: 00383790000154
• Combination Product (y/n): N
• PMA/PMN Number: K063721
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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 Manufacturer Received: 04/17/2020
• Initial Date FDA Received: 05/08/2020
• Supplement Dates Manufacturer Received: 04/17/2020
• Supplement Dates FDA Received: 06/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other