MAUDE Adverse Event Report: JIANGSU CAINA MEDICAL CO.,LTD CAINA; SYRINGE, PISTON

Model Number	322701
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Upon opening the sterile caina syringe with safety needle, it was observed that there was no plunger on the stem.Not used on patient.Manufacturer response for syringe, piston, caina (per site reporter), will obtain.

• Brand Name: CAINA
• Common Device Name: SYRINGE, PISTON
• Manufacturer (Section D): JIANGSU CAINA MEDICAL CO.,LTD; 2219 rimlang drive, suite 301; bellingham WA 98226
• MDR Report Key: 19058839
• Report Number: 19058839
• Device Sequence Number: 6017250
• Product Code: FMF
• UDI-Device Identifier: 06971564465090
• UDI-Public: (01)06971564465090(17)089720100001(10)20250930
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 03/15/2024
• Report Date (Section F): 03/15/2024

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: 322701
• Device Catalogue Number: CA3227
• Device Lot Number: 20250930
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 04/08/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/08/2024
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 03/15/2024