TwoFer Needle 16004Recalls & reported problems
Medsafety Solutions LLC · TwoFer Huber-Tipped Needle · Class 2
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00853832007071), received between Dec 2, 2024 and Dec 2, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Product Quality Problem” (1 report).
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
- Product Quality Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 2, 2024Product Quality Problem; Product Quality Problem
RECEIVED COMMUNICATION FROM PRODUCT DISTRIBUTER LOCATED IN FINLAND THAT A CUSTOMER REPORTED "PARTICLES" OBSERVED IN SEVERAL BATCHES OF COMPOUNDED SOLUTIONS. THE TWOFER NEEDLE WAS UTILIZED IN THE COMPOUNDING PROCESS. THE 'INCIDENT DATE' WAS NOT REPORTED. THE REPORTED INCIDENT HAD NO PATIENT INVOLVEMENT; IT DID NOT RESULT OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY. THE INCIDENT IS CURRENTLY UNDER INVESTIGATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20828087 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.