MAUDE Adverse Event Report: JIANGSU CAINA MEDICAL CO.,LTD CAINA; DISPOSABLE SYRINGE, 1CC LUER LOCK

Model Number	SN01001
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Event or Problem Description
Complaint reporter indicated the following via e-mail on 15-march-2022: "the needle safety doesn't click into place reliably." the event date for the reported lot number is unknown.
Additional Manufacturer Narrative
Mckesson medical-surgical, inc.Is the assembler of convenience kits that can contain the device from the manufacturer identified in section d.The item ref # and lot # reported and identified in section d has been confirmed as having been used in the assembly of convenience kits supplied by mckesson medical-surgical, inc.We have notified asprsnsopscell@cdc.Gov and barda-rqaproductacceptance@hhs.Gov for awareness.

• Brand Name: CAINA
• Common Device Name: DISPOSABLE SYRINGE, 1CC LUER LOCK
• Manufacturer (Section D): JIANGSU CAINA MEDICAL CO.,LTD; no.23, huanxi road, zhutang; jiangyin cn-32; jiangsu 21441 5; CH 214415
• Manufacturer (Section G): MCKESSON MEDICAL-SURGICAL, INC.; 9954 mayland drive; richmond VA 23233
• Manufacturer Contact: jo ann silverthorne ; 9954 mayland drive; richmond, VA 23233 ; 8045532278
• MDR Report Key: 14113689
• Report Number: 3017368639-2022-00021
• Device Sequence Number: 4612925
• Product Code: FMF
• UDI-Device Identifier: 06971564465267
• UDI-Public: 06971564465267
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K192551
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 04/12/2022

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: 03/31/2026
• Device Model Number: SN01001
• Device Catalogue Number: CN2515
• Device Lot Number: 210401
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/15/2022
• Initial Report FDA Received Date: 04/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown