Jelco 402558Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00351688066551), received between Feb 22, 2017 and Jul 1, 2025 — classified as 4 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Bent” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 1, 2025Obstruction of Flow; Blocked Connection; Obstruction of Flow; Blocked Connection

  IT WAS STATED THAT THE NEEDLE WAS GIVING A RESISTANCE NOT ABLE TO PUSH MEDICATION THROUGH THE NEEDLE. THERE WAS PATIENT INVOLVEMENT, BUT NO HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22373692 ↗
• MalfunctionMar 27, 2025Disconnection; Disconnection

  IT WAS REPORTED THAT THE NEEDLE SEPARATED/UNSCREWED FROM THE PROTECTIVE PLASTIC. THERE WAS UNKNOWN PATIENT INVOLVEMENT AND UNKNOWN PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21707819 ↗
• MalfunctionFeb 4, 2025Obstruction of Flow; Blocked Connection; Obstruction of Flow; Blocked Connection

  IT WAS STATED THAT THE NEEDLE WAS GIVING A RESISTANCE NOT ABLE TO PUSH MEDICATION THROUGH THE NEEDLE. THERE WAS PATIENT INVOLVEMENT, BUT NO HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21305002 ↗
• MalfunctionDec 6, 2024Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  IT WAS REPORTED THAT THE NEEDLES WERE LEAKING AS WELL AS BREAKING OFF THE SYRINGE. WE ALSO RECEIVED REPORTS OF HEALTH PROVIDERS STICKING PATIENTS WITH THE NEEDLES AND THEN UPON RETRACT, THEY WERE BREAKING AND GETTING STUCK WITHIN THE PATIENTS. THERE WAS PATIENT INVOLVEMENT AND UNKNOWN PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20865680 ↗
• MalfunctionNov 14, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING AN INTENDED FLU VACCINE PROCEDURE, THE FLU VACCINE LEAKED OUT. THE CUSTOMER STATED THAT THEY FELT THIS WAS DUE TO THE HUB NOT BEING TIGHT. ANOTHER VACCINE WAS OBTAINED AND GIVEN TO THE PATIENT WITH NO PATIENT HARM RESULTING FROM THE EVENT. THE CUSTOMER STATES THAT LEAKING FROM THE PRE-FILLED SYRINGES HAS BEEN AN ONGOING ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20689372 ↗
• MalfunctionNov 4, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT AFTER INJECTING THE FLU VACCINE INTO THE PATIENT'S RIGHT THIGH, THE NEEDLE DETACHED FROM THE HUB DURING REMOVAL AND REMAINED IN THE PATIENT'S LEG. ALL OF THE VACCINE WAS INJECTED. NO HARM RESULTED; NEEDLE WAS IMMEDIATELY REMOVED. OPERATOR OF DEVICE WAS A HEALTH PROFESSIONAL. THE LOCATION WHERE EVENT OCCURRED WAS IN AN OUTPATIENT TREATMENT FACILITY. THERE WAS A PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20598882 ↗
• MalfunctionOct 21, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THERE WAS A NEEDLE MALFUNCTION/LUER LOCK BECAME LOOSE, HEPARIN WAS SPRAYED OUTSIDE OF SYRINGE. THERE WAS ESTIMATED 75% OF SCHEDULED DOSE DELIVERED. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20498502 ↗
• MalfunctionOct 9, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT WHEN INJECTING INTO THE LEG, LIQUID SQUIRTED OUT THE SIDE OF THE SIDE OF THE NEEDLE INSTEAD OF GOING THROUGH AND IM INTO THE LEG. THERE WAS PATIENT INVOLVEMENT, AND UNKNOWN PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20408079 ↗
• MalfunctionApr 13, 2022Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT WHEN THE NURSE CAPPED THE SYRINGE, THE NEEDLE WENT THROUGH THE ORANGE CAP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14102928 ↗
• InjuryAug 18, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A DIRTY NEEDLESTICK OCCURED USING A JELCO® HYPODERMIC NEEDLE-PRO® EDGE¿ SAFETY DEVICE. THE USER WAS A NURSE. NO OTHER KNOWN INJURY WAS REPORTED.

  Patient problems: Needle Stick/Puncture

  MAUDE report 6805206 ↗
• InjuryFeb 22, 2017Bent; Protective Measures Problem; Bent; Protective Measures Problem

  IT WAS REPORTED THAT A JELCO® HYPODERMIC NEEDLE-PRO® EDGE¿ SAFETY DEVICE WAS ACTIVATED DURING USE AND UPON ACTIVATION, THE NEEDLE BENT OUT OF THE SAFETY DEVICE AND THE CLINICIAN EXPERIENCED A NEEDLESTICK. IT WAS NOTED THAT THE CLINICIAN ACTIVATED THE DEVICE AWAY FROM THEMSELVES ON A HARD SURFACE. THE CLINICIAN WAS TESTED, EVALUATED, AND COUNSELED RELATED TO THE INCIDENT. NO PERMANENT INJURY WAS REPORTED. SEE MFR: 3012307300-2017-00509 AND 3012307300-2017-00575.

  Patient problems: Needle Stick/Puncture

  MAUDE report 6350178 ↗
• InjuryFeb 22, 2017Bent; Protective Measures Problem; Bent; Protective Measures Problem

  IT WAS REPORTED THAT A JELCO HYPODERMIC NEEDLE-PRO EDGE SAFETY DEVICE WAS ACTIVATED DURING USE AND UPON ACTIVATION, THE NEEDLE BENT OUT OF THE SAFETY DEVICE AND THE CLINICIAN EXPERIENCED A NEEDLESTICK. IT WAS NOTED THAT THE CLINICIAN ACTIVATED THE DEVICE AWAY FROM THEMSELVES ON A HARD SURFACE. THE CLINICIAN WAS TESTED, EVALUATED, AND COUNSELED RELATED TO THE INCIDENT. NO PERMANENT INJURY WAS REPORTED. SEE MFR: 3012307300-2017-00509 AND 3012307300-2017-00510.

  Patient problems: Needle Stick/Puncture

  MAUDE report 6350177 ↗
• InjuryFeb 22, 2017Bent; Protective Measures Problem; Bent; Protective Measures Problem

  IT WAS REPORTED THAT A JELCO® HYPODERMIC NEEDLE-PRO® EDGE¿ SAFETY DEVICE WAS ACTIVATED DURING USE AND UPON ACTIVATION, THE NEEDLE BENT OUT OF THE SAFETY DEVICE AND THE CLINICIAN EXPERIENCED A NEEDLESTICK. IT WAS NOTED THAT THE CLINICIAN ACTIVATED THE DEVICE AWAY FROM THEMSELVES ON A HARD SURFACE. THE CLINICIAN WAS TESTED, EVALUATED, AND COUNSELED RELATED TO THE INCIDENT. NO PERMANENT INJURY WAS REPORTED. SEE MFR: 3012307300-2017-00510 AND 3012307300-2017-00575.

  Patient problems: Needle Stick/Puncture

  MAUDE report 6350170 ↗