MAUDE Adverse Event Report: SHANGHAI KINDLY ENTERPRISE DEVELOPMENT GROUP CO MCKESSON BRANDS; SYRINGE/NDL, TB 1CC 25GX5/8"

Catalog Number	16-SNT1C2558
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/03/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the customer that foreign matter was found within the syringe.The foreign matter was adhered to the rubber stopper.No information was received regarding any serious injury as a result of this reported issue.

• Brand Name: MCKESSON BRANDS
• Common Device Name: SYRINGE/NDL, TB 1CC 25GX5/8"
• Manufacturer (Section D): SHANGHAI KINDLY ENTERPRISE DEVELOPMENT GROUP CO; no. 658, gao chao rd., jiading; shanghai, shanghai 20180 3; CH 201803
• MDR Report Key: 18228640
• Report Number: 1451040-2023-00055
• Device Sequence Number: 6155970
• Product Code: FMF
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 11/29/2023
• Report Date (Section F): 11/29/2023

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 Catalogue Number: 16-SNT1C2558
• Device Lot Number: CKDC06-01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 11/03/2023
• Device Age: 5 MO
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 11/29/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/29/2023
• 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: 11/29/2023