MAUDE Adverse Event Report: LIFELONG MEDITECH PRIVATE LIMITED MCKESSON BRANDS; SYRINGE, LL 60CC

Catalog Number	16-S60C
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the customer that 2 syringes have had the luer lock tip come off during use.No information was received regarding any serious injury as a result of these product issues.

• Brand Name: MCKESSON BRANDS
• Common Device Name: SYRINGE, LL 60CC
• Manufacturer (Section D): LIFELONG MEDITECH PRIVATE LIMITED; plot no. 18, sector-5; imt manesar; gurgaon, 12205 0; IN 122050
• MDR Report Key: 23764604
• Report Number: 1451040-2025-00119
• Device Sequence Number: 13189405
• Product Code: FMF
• UDI-Device Identifier: 20612479273218
• UDI-Public: 20612479273218
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 12/09/2025
• Report Date (Section F): 12/09/2025

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-S60C
• Device Lot Number: 042560-E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 11/17/2025
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 12/09/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/09/2025
• 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: 12/09/2025