Monoject 1182558Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10884521544710), received between May 23, 2019 and Jan 16, 2026 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (5 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 16, 2026Decoupling; Fluid/Blood Leak

  CUSTOMER REPORTED THAT DURING THE INJECTION OF THE VARIVAX, TOWARDS THE END OF THE INJECTION VOLUME AMOUNT, THE NEEDLE SEPARATED/UNSCREWED ITSELF FROM THE SYRINGE. THE REMAINING VOLUME OF VARIVAX LEAKED OUT OF THE SYRINGE AND WAS SUBSEQUENTLY NOT ADMINISTERED TO THE PATIENT. APPROXIMATELY 0.1ML-0.2 ML APPEARED TO BE THE AMOUNT THAT LEAKED OUT. PATIENT RECEIVED MAJORITY OF TOTAL VOLUME AMOUNT. IT APPEARS THAT THE NEEDLE AND SYRINGE DID NOT HAVE A GOOD SEAL, DESPITE MY EFFORTS OF ENSURING A SUFFICIENT SEAL X 2 (BEFORE DRAWING UP THE VACCINE AND AFTER DRAWING UP THE VACCINE), LEADING TO THE DETACHMENT OF THE TWO DEVICES DURING THE INJECTION. MD NOTIFIED, I DISCUSSED WITH DAD THAT I FELT AS IF THE PATIENT RECEIVED THE MAJORITY OF THE VOLUME INJECTION AND DAD AGREED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24092472 ↗
• MalfunctionNov 13, 2023Break; Fluid/Blood Leak; Fail-Safe Problem; Break; Fluid/Blood Leak; Fail-Safe Problem

  THE CUSTOMER REPORTED THAT THE RN PULLED UP AN IMMUNIZATION XX INTO A 3 CC SYRINGE USING A BLUNT NEEDLE. AFTERWARD RN REPLACED WITH A HYPODERMIC SAFETY NEEDLE. RN WAS ABLE TO PRIME THE NEEDLE WITHOUT EVENT. RN CLEANSED THE PATIENT'S SKIN WITH AN ALCOHOL SWAB. THIS RN GENTLY SQUEEZED THE SKIN ON THE RIGHT VAS LATERALIS WITH LEFT HAND AND INJECTED NEEDLE AT A 90-DEGREE ANGLE WITH A QUICK THRUST WITH THE RIGHT. RN USED NO MORE FORCE THAN THIS RN TYPICALLY USES FOR IM INJECTION. WHEN INJECTION WAS GIVEN ALL OR MOST OF THE IMMUNIZATION EXPELLED OUT THE SIDE OF THE SYRINGE ALONG THE LUER LOCK OF THE NEEDLE. UPON INSPECTION OF THE NEEDLE AFTER INJECTION, THE NEEDLE WAS SLIGHTLY BENT AND THE HYPODERMIC SAFETY NEEDLE ITSELF LOOKED DAMAGED AT THE LUER LOCK SITE. ADDITIONAL INFORMATION RECEIVED ON 26OCT2023 STATED THAT THEY USED THE NEEDLE WITH A BD PLASTI PAK 3 ML SYRINGE LOT 2181846 . THEY TWISTED THE HUB INTO THE LUER UNTIL IT WOULD NOT TWIST ANYMORE. THE NEEDLE DID NOT APPEAR TO BE BENT PRIOR TO THE INJECTION. THE AREA THAT LOOKED DAMAGED WAS THE HUB WHERE IT ATTACHES TO THE LUER LOCK. IT WAS AS IF THE ENTIRE DEVICE SHIFTED FORWARD STARTING AT A BEND IN THE HUB. THIS WAS NOT NOTICED WHEN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18126597 ↗
• MalfunctionAug 7, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  CUSTOMER REPORTS: THE NEEDLE FALLS OFF THE SYRINGE (PACKAGED NEEDLE/SYRINGE).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17470531 ↗
• MalfunctionAug 7, 2023Fluid/Blood Leak; Detachment of Device or Device Component; Fluid/Blood Leak; Detachment of Device or Device Component

  ADDITIONAL INFORMATION PROVIDED BY THE CUSTOMER ON (B)(6)STATED THAT IN THIS CASE THE NEEDLE DID NOT DETACH AS ORIGINALLY REPORTED, HOWEVER, THE NURSE PRACTITIONERS FEEL THAT THIS OCCURS DUE TO THE MANUFACTURING OF THE NEEDING AND THE CAP. IN THIS CASE THE NEEDLE LEAKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17470510 ↗
• MalfunctionJun 22, 2022Crack; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT THE SIDE OF THE ORANGE NEEDLE HAD A SLIGHT SPLIT IN THE PLASTIC RESULTING IN TREATMENT BEING LEAKED ONTO THE NURSE ADMINISTERING IT. NO HARM OR INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14775308 ↗
• MalfunctionApr 14, 2022Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT THE SIDE OF THE ORANGE NEEDLE HAD A SLIGHT SPLIT IN THE PLASTIC RESULTING IN TREATMENT BEING LEAKED ONTO THE NURSE ADMINISTERING IT. NO HARM OR INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14112883 ↗
• InjuryMay 23, 2019Fail-Safe Problem; Fail-Safe Problem

  THE CUSTOMER REPORTED THE SAFETY DEVICE SNAPPED WHEN THEY WERE ATTEMPTING TO COVER THE NEEDLE CAUSING A NEEDLE STICK INJURY. THE NEEDLE STICK INJURY REQUIRED FOLLOW UP PROTOCOL FOR NEEDLE STICK INJURIES, INCLUDING BLOOD SAMPLES AND INCIDENT REPORTING.

  Patient problems: Needle Stick/Puncture

  MAUDE report 8636365 ↗