MAUDE Adverse Event Report: SHANDONG WEIGAO GROUP MEDICAL POLYMER CO., LTD SYRINGE - 10CC; NIPRO 10CC LL SYRINGE

Model Number	JD+10L-WEI
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/28/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
Syringe tip broke off inside of patient's dialysis catheter, prior to treatment, pulling heparin out of the catheter lumen.No injuries, medical interventions or hospitalization were reported.The syringe tip was removed with needle nose plyers.Patient returned to their regular scheduled treatment without further issues.Brand of dialysis catheter is unknown.Customer also reported the same issue occurring with bloodlines(braun streamline airless system) occurring with patients using avf graft/fistula.While twisting the needle into the medication port, as well as while placing a needle on the syringe.No further information was provided.

• Brand Name: SYRINGE - 10CC
• Common Device Name: NIPRO 10CC LL SYRINGE
• Manufacturer (Section D): SHANDONG WEIGAO GROUP MEDICAL POLYMER CO., LTD; 20 xingshan road; hight tech industrial; development, weihai 267-2 09; CH 267-209
• MDR Report Key: 10930981
• Report Number: 1056186-2020-00017
• Device Sequence Number: 2542697
• Product Code: FMF
• UDI-Device Identifier: 00383790001007
• UDI-Public: 00383790001007
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 12/01/2020
• Report Date (Section F): 12/01/2020

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: 01/31/2025
• Device Model Number: JD+10L-WEI
• Device Catalogue Number: JD+10L-WEI
• Device Lot Number: 20200218
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 11/04/2020
• Device Age: 8 MO
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 12/01/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/01/2020
• 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: 12/01/2020