MAUDE Adverse Event Report: LIFELONG MEDITECH PRIVATE LIMITED MCKESSON BRAND; SYRINGE, LS W/O NDL 1CC

Catalog Number	16-S1CLS
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/26/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the needle does not stay properly on the syringe and comes off.On (b)(6) 2025, the customer responded to the probing questions and confirmed that there were no patient injuries; however, medication leakage did occur.

• Brand Name: MCKESSON BRAND
• Common Device Name: SYRINGE, LS W/O NDL 1CC
• Manufacturer (Section D): LIFELONG MEDITECH PRIVATE LIMITED; plot no. 18, sector-5, imt man; gurgaon, 12205 0; IN 122050
• MDR Report Key: 23889683
• Report Number: 1451040-2025-00123
• Device Sequence Number: 9650670
• Product Code: FMF
• UDI-Device Identifier: 10612479275604
• UDI-Public: 10612479275604
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 12/24/2025
• Report Date (Section F): 12/24/2025

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-S1CLS
• Device Lot Number: 032501-K
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 12/19/2025
• Device Age: 12 MO
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 12/24/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/24/2025
• 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: 12/24/2025