MAUDE Adverse Event Report: JIANGSU CAINA MEDICAL CO.,LTD MCKESSON BRANDS; SYRINGE/NDL, TB 1CC 25GX5/8"

Catalog Number	16-SNT1C2558
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/05/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the customer that the needles were leaking and that the caps were difficult to remove.To remove the cap, the needle must be held tightly, loosening the needle and resulting in leakage.No information was received regarding any serious injury as a result of this product issue.

• Brand Name: MCKESSON BRANDS
• Common Device Name: SYRINGE/NDL, TB 1CC 25GX5/8"
• Manufacturer (Section D): JIANGSU CAINA MEDICAL CO.,LTD; no.23 huanxi rd; zhutang town; jiangyin city, jiangsu ; CH
• MDR Report Key: 19955430
• Report Number: 1451040-2024-00040
• Device Sequence Number: 8801270
• Product Code: FMF
• UDI-Device Identifier: 10612479207292
• UDI-Public: 10612479207292
• 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): 08/09/2024
• Report Date (Section F): 08/09/2024

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: CJCC07-01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/18/2024
• Device Age: 12 MO
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 08/09/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/09/2024
• 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: 08/09/2024