Medline SSN101272FRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10193489037838), received between Apr 6, 2024 and Sep 12, 2026 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 12, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50746642 ↗
• MalfunctionSep 9, 2026Dull, Blunt

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50692876 ↗
• MalfunctionJul 26, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  THE REPORTING FACILITY INDICATED THAT THE NEEDLE IS DULL. TO DATE, NO INFORMATION HAS BEEN RECEIVED TO INDICATE THAT THERE WAS A SYRINGE- RELATED DEFECT RELATED TO THE ORIGINAL REPORT OR THAT THE REPORT INVOLVED AN OUT OF SPECIFICATION SYRINGE. TO DATE, NO INFORMATION HAS BEEN RECEIVED TO INDICATE THAT A USER OR A PATIENT EXPERIENCED A DEATH, SERIOUS INJURY, MEDICAL INTERVENTION, FOLLOW-UP CARE, OR OTHER ADVERSE HEALTH IMPACT ASSOCIATED WITH THE REPORTED PROBLEM/ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19834871 ↗
• MalfunctionJul 26, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  ACCORDING TO THE CUSTOMER, THERE WERE 2 INCIDENCES OF A NEEDLE STICK AFTER ADMINISTERING HEPARIN'. THE CUSTOMER REPORTED THE NEEDLE WAS FOUND TO BE POKING OUT OF THE SMALL SQUARE OPENING ON THE SAFETY SHIELD'. ACCORDING TO THE CUSTOMER, BOTH PATIENTS THE NEEDLE WAS USED ON WERE NEGATIVE FOR HIV, HEPATITIS B AND C, SO NO PROPHYLAXIS WAS RECOMMENDED OR TAKEN'. THE CUSTOMER REPORTED NO MEDICAL INTERVENTION OR SERIOUS INJURY OCCURRED RELATED TO THIS EVENT. SAMPLE REQUESTED TO BE RETURNED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THERE WAS NO SERIOUS INJURY IDENTIFIED, FOLLOW UP CARE NEEDED OR MEDICAL INTERVENTION REPORTED RELATED TO THE INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19834849 ↗
• MalfunctionJun 23, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  THE CUSTOMER STATED WHEN THEY USE THE SYRINGES THE CAPS KEEP POPPING OFF. SAID IT'S HAPPENED ABOUT 25-30 TIMES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19591779 ↗
• MalfunctionApr 6, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE NEEDLE/SYRINGE CAPS WERE LOOSE WITHIN THE DEVICE PACKAGING AND THAT THE CAPS WOULD NOT STAY ON THE NEEDLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19056515 ↗