MAUDE Adverse Event Report: SHANDONG WEIGAO GROUP MEDICAL POLYMER CO., LTD NIPRO 10CC LL SYRINGE WITHOUT NEEDLE

Model Number	JD+10L-WEI
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/05/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
Staff removed the tego (day to change them) & attached an empty / no needle 10cc syringe to withdraw what was presently in the venous lumen.Staff obtained approx.5 cc solution and immediately went to put the new tego on to the venous lumen.At that time the staff noticed there was something inside the lumen that was preventing from attaching the new tego.Staff attempted for 20 min, to get this plastic piece out of the venous lumen.Treatment lines could not be attached to the venous lumen to start the treatment.Patient's physician was notified.The physician went to the clinic to see the situation and attempt to remove the plastic that was in the venous lumen.He was unsuccessful.Doctor called the vascular physician to tell him about the situation.The vascular physician was able to get the plastic piece out of the venous lumen.According to the staff, the patient was able to complete their scheduled treatment.Incident occurred during catheter preparation for treatment, before treatment started.

• Brand Name: NIPRO 10CC LL SYRINGE WITHOUT NEEDLE
• Common Device Name: SYRINGE
• Manufacturer (Section D): SHANDONG WEIGAO GROUP MEDICAL POLYMER CO., LTD; 20 xingshan road; address2 hight tech industrial; weihai 267-2 019; CH 267-2019
• MDR Report Key: 10632314
• Report Number: 1056186-2020-00009
• Device Sequence Number: 3272986
• Product Code: FMF
• UDI-Device Identifier: 00383790001007
• UDI-Public: 00383790001007
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/05/2020
• Report Date (Section F): 10/05/2020

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: 12/31/2024
• Device Model Number: JD+10L-WEI
• Device Catalogue Number: JD+10L-WEI
• Device Lot Number: 20200108
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2020
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 09/09/2020
• Device Age: 8 MO
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 10/05/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/05/2020
• 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: Required Intervention
• Date Report Sent to FDA: 10/05/2020