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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MCKESSON BRANDS; NEEDLE, HYPO TW 25GX1 1/2"
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MCKESSON BRANDS; NEEDLE, HYPO TW 25GX1 1/2" Back to Search Results
Catalog Number 16-N25105
Medical Device Problem Code Complete Blockage (1094)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 08/26/2025
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
This product is sourced from more than one manufacturer.The customer could not provide a lot number allowing for identification of the manufacturer.
 
Event or Problem Description
The customer reported that the needles would not allow fluid to exit to be injected.No information was received regarding any serious injury as a result of this product issue.
 
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Brand Name
MCKESSON BRANDS
Common Device Name
NEEDLE, HYPO TW 25GX1 1/2"
MDR Report Key23048892
Report Number1451040-2025-00084
Device Sequence Number9825020
Product Code FMI
UDI-Device Identifier10612479206769
UDI-Public10612479206769
Combination Product (Y/N)N
Initial Reporter StateFL
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) 09/15/2025
Report Date (Section F) 09/15/2025
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 Number16-N25105
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Distributor Facility Aware Date08/26/2025
Device Age12 MO
Event Location Outpatient Treatment Facility
Date Report to Manufacturer09/15/2025
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date09/15/2025
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 FDA09/15/2025
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