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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIFELONG MEDITECH PRIVATE LIMITED MCKESSON BRANDS; SYRINGE, LL 5CC

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LIFELONG MEDITECH PRIVATE LIMITED MCKESSON BRANDS; SYRINGE, LL 5CC Back to Search Results
Catalog Number 16-S5C
Medical Device Problem Codes Crack (1135); Leak/Splash (1354)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 01/06/2026
Type of Reportable Event Malfunction
Event or Problem Description
It was reported by the customer that when injecting a patient, the syringe broke by splitting longitudinally and medication spilled to the floor.
 
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Brand Name
MCKESSON BRANDS
Common Device Name
SYRINGE, LL 5CC
Manufacturer (Section D)
LIFELONG MEDITECH PRIVATE LIMITED
plot no. 18, sector-5
imt manesar
gurgaon, 12205 0
IN  122050
MDR Report Key24072748
Report Number1451040-2026-00005
Device Sequence Number13062962
Product Code FMF
UDI-Device Identifier10612479207001
UDI-Public10612479207001
Combination Product (Y/N)N
Initial Reporter StateCT
Initial Reporter CountryUS
Number of Events Summarized1
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) 01/14/2026
Report Date (Section F) 01/14/2026
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 Number16-S5C
Device Lot Number052505-R
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Distributor Facility Aware Date01/06/2026
Device Age12 MO
Event Location Outpatient Treatment Facility
Date Report to Manufacturer01/14/2026
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date01/14/2026
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)
No
Patient Sequence Number1
Patient SexUnknown
Date Report Sent to FDA01/14/2026
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