MAUDE Adverse Event Report: JIANGSU CAINA MEDICAL CO., LTD. MCKESSON BRANDS; SYRINGE/NDL, LL 3CC 21GX1"

Catalog Number	16-SN3C211
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	07/27/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the customer that the caps are loose or already off when removing the syringes from the box.A technician poked himself twice due to the cap sliding off by itself when he peeled open an individual pack.This would have been a clean stick.No information was received regarding any serious injury as a result of this report.

• Brand Name: MCKESSON BRANDS
• Common Device Name: SYRINGE/NDL, LL 3CC 21GX1"
• Manufacturer (Section D): JIANGSU CAINA MEDICAL CO., LTD.; no. 23 huanxi rd; zhutang town, jiangyin city ; CH
• MDR Report Key: 15223611
• Report Number: 1451040-2022-00047
• Device Sequence Number: 4572534
• Product Code: FMF
• Combination Product (Y/N): N
• Initial Reporter State: NV
• 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): 08/12/2022
• Report Date (Section F): 08/12/2022

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 Catalogue Number: 16-SN3C211
• Device Lot Number: CJCB03-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/27/2022
• Device Age: 4 MO
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 08/12/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/15/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 08/12/2022