MAUDE Adverse Event Report: JIANGSU CAINA MEDICAL CO.,LTD. MCKESSON BRANDS; SYRINGE,LL 20CC

Model Number	16-S20C
Health Effect - Clinical Codes	Eye Injury (1845); Chemical Exposure (2570)
Date of Event	03/11/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A returned sample had been evaluated and it was concluded that syringe cracked from assembly equipment.The production process of the syringe had been reviewed, and the equipment may cause the syringe to crack under some unexpected condition.However, all syringes can not be released until after staff examination.All the assembled equipment of syringe be perform to improve, which helps to reduce syringe to crack.We had also changed the staff's inspection process, and a staff will be replaced at intervals of not more than 2 hours by other staff to relieve eye fatigue.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports.We will review the collected data for identification of emerging trends.
Event or Problem Description
It was reported that an employee was sprayed in the eyes with a chemotherapy drug,carboplatin causing chemical abrasions to the right eye.The 20ml syringe cracked during injection of the drug into a bag.Antibiotic drops and an ophthalmologist follow up were required.

• Brand Name: MCKESSON BRANDS
• Common Device Name: SYRINGE,LL 20CC
• Manufacturer (Section D): JIANGSU CAINA MEDICAL CO.,LTD.; no.23 huanxi rd.,zhutang town; jiangyin, jiangsu 21441 5; CH 214415
• MDR Report Key: 16045722
• Report Number: 3005670221-2022-00003
• Device Sequence Number: 6220452
• Product Code: FMF
• UDI-Device Identifier: 10612479206912
• UDI-Public: 10612479206912
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K113091
• Number of Events Summarized: 1
• Summary Report (Y/N): Y
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/04/2022

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
• Device Expiration Date: 08/31/2026
• Device Model Number: 16-S20C
• Device Catalogue Number: 16-S20C
• Device Lot Number: CJCA09-03
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/17/2022
• Initial Report FDA Received Date: 12/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2021
• 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