MCKESSON
Received Jul 2, 2026 · Event occurred May 14, 2026
Report 3014312726-2026-00051 · MDR key 25689312
Device
Generic name
Needle, Safety 25gx1" (hinged Style)
Manufacturer
Sol-millennium Medical IncModel number
16-N251SLot number
CSOE04-01
Product problems
- Decoupling
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
CUSTOMER REPORTED THAT THEY HAD A FEW SITUATIONS WHERE THESE NEEDLES HAVE COME OFF OUR PRE-FILLED SYRINGES. ONE INSTANCE WAS IN A PATIENT'S ARM; OTHERS HAVE BEEN WHILE PREPPING THE VACCINES. THESE ARE USED FOR VACCINES. THERE HAVE BEEN SEVERAL DIFFERENT VACCINES WHERE THESE NEEDLES HAVE COME OFF AND WON'T GO BACK ON. (HEPATITIS A, PENTACEL, HPV TO NAME A FEW). WE USE THESE NEEDLES ONLY TO ADMINISTER VACCINES/ MEDICATIONS TO PATIENTS. WE DO NOT USE THEM TO DRAW UP THE MEDICATION.
Additional Manufacturer Narrative
THE MANUFACTURING BATCH RECORDS FOR THE AFFECTED LOT (CSOE04-01), ARCHIVED SAMPLES, AND RETURNED CUSTOMER SAMPLES (LOTS CSOE04-01 AND 07502014) WERE EVALUATED AS PART OF THE INVESTIGATION. NO EVIDENCE OF A MANUFACTURING OR PRODUCT-RELATED QUALITY ISSUE ASSOCIATED WITH THIS COMPLAINT WAS IDENTIFIED, AND THE REPORTED FAILURE MODE COULD NOT BE REPRODUCED DURING INTERNAL TESTING. BASED ON THE DETERMINED RISK PRIORITY NUMBER (RPN), THE RESIDUAL RISK ASSOCIATED WITH THIS COMPLAINT IS CONSIDERED ACCEPTABLE.