SOL-M™ Hypodermic Needle 111815Recalls & reported problems
Sol-Millennium Medical, Inc. · Sterile hypodermic needles intended to inject fluids into, or withdraw fluids from, parts of the body below the suface of the skin. · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00818392015102), received between May 16, 2025 and Jun 17, 2025 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Defective Component” (3 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Defective Component3
- Complete Blockage1
- Material Twisted/Bent1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
- Needle Stick/Puncture1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 17, 2025Defective Component; Defective Component
CUSTOMER REPORTED THAT THE 18G NEEDLE DRAW FROM MULTIDOSE VIAL SUSPECTED LEAVING FRAGMENTS OF RUBBER FROM LID IN VIAL. I HAVE RETAINED VIAL WITH FLOATING FRAGMENT. NEEDLE USED: A SOL-M 18G 2023/05 4149 REV 11 CE (B)(4). REF (B)(4). LOT 02307025. OTHER DATES WRITTEN 2023-08 AND 2028-07-20 XYLOCAINE 2% MULTIDOSE VIAL WITH EPI 1:200,000 20 ML VIAL XA254746 (PRINTED ON ALUMINIUM CAP) LOT 9954746 EXP 08/2026 DIN (B)(4) PRINTED ON LABEL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22225917 ↗MalfunctionMay 16, 2025Material Twisted/Bent; Material Twisted/Bent
CUSTOMER REPORTED TRANSLATION: THE CIRCUMSTANCES AND DESCRIPTION OF THE FACTS: THE NEEDLE TIP WAS BENT. PRICK YOURSELF BECAUSE IT'S DIFFICULT TO GET INTO THE SERUM POUCH. WASTE OF TIME IN AN EMERGENCY.
Patient problems: Needle Stick/Puncture
MAUDE report 22035746 ↗MalfunctionMay 16, 2025Complete Blockage; Complete Blockage
CUSTOMER REPORTED (TRANSLATION): VERY OFTEN, IMPRESSION THAT THE TROCARS ARE CLOGGED. IT IS DIFFICULT TO INJECT INTO THE VIALS. THIS HAPPENS WITH ANY SUBSTANCE. NOT ALL TROCARS HAVE THE SAME DEFECT BUT IT REMAINS FREQUENT. WE HAVE KEPT A DEFECTIVE EXAMPLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22035713 ↗MalfunctionMay 16, 2025Defective Component; Defective Component
CUSTOMER SAYS: I AM SENDING YOU THIS EMAIL FOLLOWING TWO COMPLAINTS EVENTS AT THE (B)(6) HOSPITAL CENTER, ABOUT THE FOLLOWING DEVICE: HYPODERMIC NEEDLE 18G (1.2MM X 40MM). SOL - M. REF: (B)(4). LOT: 02310012. DDP: 15.10.2028. DDF: 11.2023. I WOULD LIKE TO SHIP OUT THE DEVICES FOR ANALYSIS IN ORDER TO DETERMINE IF THERE IS A DEFECT, CAUSING THE RUBBER CORING WITH THE ANTIBIOTIC BOTTLE. PLEASE NOTE THAT IT'S A RECURRING EVENT. YOU WILL FIND IN ATTACHED THE SCREENSHOT OF THE DECLARED ISSUE AS WELL AS THE PHOTOS OF THE BOTTLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22035609 ↗MalfunctionMay 16, 2025Defective Component; Defective Component
CUSTOMER REPORTED: WHEN USING THE HYPODERMIC NEEDLE (REF: 111815) TO COLLECT MEDICATIONS PRESENTED IN A BOTTLE WITH A PLASTIC TIP RUBBER, A PIECE OF RUBBER FOUND IN THE SYRINGE FROM CORING ISSUE. THIS ISSUE SEEMS TO OCCUR INDEPENDENTLY OF THE BATCH NUMBER (UNDERSTAND OFTEN).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22035557 ↗
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- N/A 305106Becton, Dickinson And Company · Needle, hypodermic, single lumen1 recall467 reports
- N/A 305110Becton, Dickinson And Company · Needle, hypodermic, single lumen418 reports
- BD Safe-Clip 328235Becton, Dickinson and Company Inc · Needle, hypodermic, single lumen268 reports
- BD Ultra-Fine 320109Becton Dickinson Pen Limited · Needle, hypodermic, single lumen229 reports
- BD AutoShield Duo 329515Becton, Dickinson And Company · Needle, hypodermic, single lumen208 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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