MAUDE Adverse Event Report: SHANDONG WEIGAO GROUP MEDICAL POLYMER CO., LTD NIPRO DISPOSABLE SYRINGE W/NEEDLE; SYRINGE WITH NEEDLE

Model Number	JD+10L2025-WEI
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
On 5/7/19, reviewed the complaint details with renal director of sales and education due to another complaint received for the same issue.It was determined that we should revise the complaint to an mdr reportable event because if the event were to recur with a patient' that had a dialysis catheter, a medical intervention would be required.We revised the complaint form and resent the updated form to the manufacturer on may 7, 2019.(b)(4).
Event or Problem Description
The syringe was connected to the avf needle tubing and heparin was flushed into the avf needle tubing, the luer lock tip of the syringe breaks off into the avf needle tubing.After this happened the staff removed the avf needle from the patient's access, re-cannulated with a new avf needle in order to complete treatment.Exact date of occurrence was unknown: estimated (b)(6) 2019.3 different lot numbers involved: 20170915, 20170815, 20170615.

• Brand Name: NIPRO DISPOSABLE SYRINGE W/NEEDLE
• Common Device Name: SYRINGE WITH NEEDLE
• Manufacturer (Section D): SHANDONG WEIGAO GROUP MEDICAL POLYMER CO., LTD; 20 xingshan road; hight tech industrial developm; weihai, 267-2 09; CH 267-209
• MDR Report Key: 8676938
• Report Number: 1056186-2019-00005
• Device Sequence Number: 2372801
• Product Code: FMF
• UDI-Device Identifier: 00383790001014
• UDI-Public: 00383790001014
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/06/2019
• Report Date (Section F): 06/06/2019

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 Model Number: JD+10L2025-WEI
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 03/28/2019
• Device Age: 17 MO
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 03/28/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/06/2019
• 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
• Date Report Sent to FDA: 06/06/2019