Monoject 11812705 (UDI 10884521544796)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10884521544796), received between Apr 6, 2022 and May 29, 2025 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device 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.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 29, 2025Decoupling; Decoupling

  "CUSTOMER REPORTED THAT THEY ARE EXPERIENCING A COUPLE OF NEEDLESTICKS WITH THE SYRINGE/NEEDLE SET, MONOJECT 27G X 1/2" NEEDLE. THE NEEDLE STICKS HAVE OCCURRED AFTER ATTEMPTING TO ENGAGE THE SAFETY CAP ON THE NEEDLE BY PRESSING THE WING TAB ON A TABLE OR OTHER HARD SURFACE. THEY ACTUALLY TEACH THIS METHOD VS USING THE OTHER HAND TO ENGAGE SAFETY CAPS. THE NEEDLE PORTION BECAME DISLODGED "POPPED OFF" FLYING BACK AT THE EMPLOYEE AND STICKING INTO THEIR HAND CAUSING A NEEDLE STICK. THE LUER-LOC DOESN'T APPEAR CRACKED OR DISTORTED IN ANY WAY.

  Patient problems: Needle Stick/Puncture

  MAUDE report 22106378 ↗
• MalfunctionJul 1, 2022Loose or Intermittent Connection; Detachment of Device or Device Component

  CUSTOMER REPORTED THAT THE NEEDLE WAS LOOSELY ATTACHED TO THE SYRINGE. THE NEEDLE UNSCREWED WHEN ACTIVATING THE SAFETY AND CAUSED A DIRTY NEEDLE STICK. ADDITIONAL INFORMATION RECEIVED FROM THE INITIAL REPORTER ON (B)(6) 2022 STATED THAT THE ENTIRE NEEDLE AND COLORED HUB DETACHED FROM THE SYRINGE. THE SITE WAS IMMEDIATELY WASHED WITH SOAP AND WATER. BLOOD TEST COMPLETED FOR HIV,SYPHILLIS, AND HEPATITIS. ALL INITIAL RESULTS WERE NEGATIVE. WILL RECHECK IN 3 MONTHS. NO FURTHER INTERVENTION DONE AS THEY REFUSED PROPHYLACTIC TREATMENT.

  Patient problems: Needle Stick/Puncture

  MAUDE report 14892764 ↗
• MalfunctionJun 22, 2022Device Difficult to Setup or Prepare; Detachment of Device or Device Component

  CUSTOMER REPORTS: WHEN THE PHYSICIAN USED A TB NEEDLE/SYRINGE TO INJECT A LOCAL ANESTHETIC ON AN INFANT, IT WAS DIFFICULT TO DRAW UP THE MEDICATION. THERE WERE MULTIPLE ATTEMPTS MADE TO FILL THE SYRINGE AND DRAW UP THE MEDICATION. WHEN REMOVING AIR FROM THE SYRINGE, THE NEEDLE PORTION FELL OFF THE SYRINGE. THE INTENDED PROCEDURE: WAS TO ADMINISTER LOCAL ANESTHETIC.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14778103 ↗
• MalfunctionJun 21, 2022Separation Problem; Fail-Safe Did Not Operate

  CUSTOMER REPORTED THAT MILTIPLE PROVIDERS HAVE HAD THE NEEDLE STUCK IN THE SKIN OF INFANT WHEN FINISHING INJECTING AND REMOVING NEEDLE. MATERIALS MANAGEMENT IS IN PROCESS OF CONTACTING THE VENDOR TO RETURN THE PRODUCT.

  Patient problems: Foreign Body In Patient

  MAUDE report 14761890 ↗
• MalfunctionApr 6, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED THAT THE NEEDLE WAS LOOSELY ATTACHED TO THE SYRINGE. THE NEEDLE UNSCREWED WHEN ACTIVATING THE SAFETY AND CAUSED A DIRTY NEEDLE STICK. ADDITIONAL INFORMATION RECEIVED FROM THE INITIAL REPORTER ON 6-APR-2022 STATED THAT THE ENTIRE NEEDLE AND COLORED HUB DETACHED FROM THE SYRINGE. THE SITE WAS IMMEDIATELY WASHED WITH SOAP AND WATER. BLOOD TEST COMPLETED FOR (B)(6). ALL INITIAL RESULTS WERE (B)(6). WILL RECHECK IN 3 MONTHS. NO FURTHER INTERVENTION DONE AS THEY REFUSED PROPHYLACTIC TREATMENT.

  Patient problems: Needle Stick/Puncture

  MAUDE report 14022451 ↗