RELI SN22G351Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00386120006758), received between Mar 22, 2017 and Dec 5, 2020 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (2 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.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 5, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED BY THE PHYSICIAN THAT THE NEEDLE DISCONNECTED FROM THE HUB DURING A PELVIS INJECTION AND WAS LEFT IN THE PATIENT. IT WAS ALSO REPORTED THIS OCCURED THREE (3) TIMES AND HE HAS USED THESE NEEDLES PREVIOUSLY. HE DID STATE THE AREA IN THE PELVIS REQUIRED HIM TO PUSH HARD INTO THE PATIENT BECAUSE IT WAS A NARROW INJECTION AREA AND WHEN HE PULLED THE NEEDLE OUT IT DISCONNECTED. ALL THREE PATIENTS WERE REPORTED TO BE MODERATELY OBESE.

  Patient problems: Foreign Body In Patient

  MAUDE report 10950317 ↗
• MalfunctionApr 18, 2017Difficult to Remove; No Apparent Adverse Event; Difficult to Remove; No Apparent Adverse Event

  IT WAS REPORTED THE STYLET OF THE NEEDLE IS STICKING; BEING DIFFICULT TO REMOVE FROM THE NEEDLE HUB WITH THE USE OF ONE HAND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 6499986 ↗
• MalfunctionMar 22, 2017Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THE STYLET OF THE NEEDLE IS STICKING; BEING DIFFICULT TO REMOVE FROM THE NEEDLE HUB WITH THE USE OF ONE HAND.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6423799 ↗