MAUDE Adverse Event Report: SHANGHAI KINDLY ENTERPRISE DEVELOPMENT GROUP CO MCKESSON BRANDS; SYRINGE, LL 10CC

Catalog Number	16-S10C
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that several syringes broke off at the hub.Based on the photos provided, the breakage occurred at the hub, causing the contents of the syringes to leak.No patient injuries were reported as a result of this issue.
Additional Manufacturer Narrative
The issue was previously reported to the fda with importer report # (b)(4).This issue was investigated with no quality issue identified.This supplemental would serve to formally withdraw the current mdr submission (importer report# (b)(4).

• Brand Name: MCKESSON BRANDS
• Common Device Name: SYRINGE, LL 10CC
• Manufacturer (Section D): SHANGHAI KINDLY ENTERPRISE DEVELOPMENT GROUP CO; no. 658, gao chao rd., jiading; shanghai; shanghai, 20180 3; CH 201803
• MDR Report Key: 22094143
• Report Number: 1451040-2025-00031
• Device Sequence Number: 7885843
• Product Code: FMF
• UDI-Device Identifier: 10612479206882
• UDI-Public: 10612479206882
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/11/2025
• Report Date (Section F): 06/11/2025

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-S10C
• Device Lot Number: CKDA10-04
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/08/2025
• Device Age: 43 MO
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 06/11/2025
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/28/2025
• Supplement Report FDA Received Date: 06/11/2025
• 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: 06/11/2025