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 5/15/19, 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, and the staff is unable to remove the broken piece, a medical intervention would be required.We revised the complaint form and resent the updated form to the manufacturer on may 15, 2019.(b)(4).
Event or Problem Description
Incidents occurred in random dates.First incident occurred on (b)(6) 2019.Another incident was noted on (b)(6) 2019.Luer lock tip found broken with needle attached inside individual packaging.Luer lock tip of syringe broke off in patient's catheter prior to treatment, staff had to remove broken piece from the patient's catheter.Luer lock tip of syringe broke in patient's fistula needle line after completion of treatment.

• 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: 8676990
• Report Number: 1056186-2019-00006
• Device Sequence Number: 2349246
• Product Code: FMF
• UDI-Device Identifier: 00383790001014
• UDI-Public: 00383790001014
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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 Expiration Date: 08/31/2022
• Device Model Number: JD+10L2025-WEI
• Device Catalogue Number: UNKNOWN
• Device Lot Number: 20170915
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 03/15/2019
• Device Age: 17 MO
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 03/15/2019
• 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