MAUDE Adverse Event Report: JIANGSU CAINA MEDICAL CO.,LTD CAINA; NEEDLE, HYPODERMIC, SINGLE LUMEN

Model Number	25501
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	09/13/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Several events with medline insulin syringe, medline sure-snap safety needle and caina safety needle.When twisting the needle onto the syringe, it does not lock properly; it spins and does not tighten down.Needles are bending when trying to pull up medication as well as when put into patient's arm.Needles have fallen out of syringe and stay in the patient's arm.The safety on the needle continues to move loosely and will flop down and not stay stationary.Safety on the needle also does not always close correctly.Some of these events have caused employee injury.Lot numbers attached are examples, but not inclusive.Manufacturer response for syringe, piston, medline (per site reporter).Unknown.Manufacturer response for needle, hypodermic, single lumen, caina (per site reporter).Unknown.

• Brand Name: CAINA
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): JIANGSU CAINA MEDICAL CO.,LTD; 2219 rimlang drive, suite 301; bellingham WA 98226
• MDR Report Key: 17974781
• Report Number: 17974781
• Device Sequence Number: 2454152
• Product Code: FMI
• UDI-Device Identifier: 06971564465021
• UDI-Public: (01)06971564465021(17)20260228(10)89721030001
• 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): 10/06/2023
• Report Date (Section F): 10/06/2023

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: 25501
• Device Catalogue Number: CA255
• Device Lot Number: 89721030001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Other
• Date Report to Manufacturer: 10/20/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/20/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 10/06/2023