MAUDE Adverse Event Report: LIFELONG MEDITECH PRIVATE LIMITED MCKESSON BRAND; SYRINGE, LL 3CC

Catalog Number	16-S3C
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported resistance when pulling the syringe plunger past the 2.5 ml mark, describing it as a "speed bump" sensation.This caused leakage during im vitamin drawing, resulting in fluid on the plunger and the staff member's hand.No information was received regarding any serious injury as a result of this product issue.

• Brand Name: MCKESSON BRAND
• Common Device Name: SYRINGE, LL 3CC
• Manufacturer (Section D): LIFELONG MEDITECH PRIVATE LIMITED; plot no. 18, sector-5, imt man; gurgaon, 12205 0; IN 122050
• MDR Report Key: 22871014
• Report Number: 1451040-2025-00076
• Device Sequence Number: 18422722
• Product Code: FMF
• UDI-Device Identifier: 10612479206974
• UDI-Public: 10612479206974
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 08/22/2025
• Report Date (Section F): 08/22/2025

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-S3C
• Device Lot Number: 032503-AV
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/04/2025
• Device Age: 12 MO
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 08/22/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/22/2025
• 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: 08/22/2025