MAUDE Adverse Event Report: JIANGSU CAINA MEDICAL CO.,LTD MCKESSON BRANDS; SYRINGE, LL 5CC

Catalog Number	16-S5C
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/20/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the customer that during the administration of a steroid to the patient, the syringe cracked and burst.However, no medication was injected.No information regarding any serious injury as a result of this product issue.

• Brand Name: MCKESSON BRANDS
• Common Device Name: SYRINGE, LL 5CC
• Manufacturer (Section D): JIANGSU CAINA MEDICAL CO.,LTD; no.23 huanxi rd; zhutang town; jiangyin, jiangsu ; CH
• MDR Report Key: 21395447
• Report Number: 1451040-2025-00004
• Device Sequence Number: 8746733
• Product Code: FMF
• UDI-Device Identifier: 10612479207001
• UDI-Public: 10612479207001
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 02/18/2025
• Report Date (Section F): 02/18/2025

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-S5C
• Device Lot Number: CJCC03-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 01/21/2025
• Device Age: 22 MO
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 02/18/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/18/2025
• 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: 02/18/2025