MEDLINE SYRSI193292Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10888277657304), received between Mar 8, 2024 and Sep 22, 2026 — classified as 15 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (8 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 18, 2026.

Most reported problems

Recent adverse event reports

The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 22, 2026Material Twisted/Bent

  It was reported that "We are having an issue with the .5 insulin needles. When they are putting it in the bottle and or taking it out they are bending."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50857298 ↗
• MalfunctionSep 18, 2026Protective Measures Problem

  Patient problems: Needle Stick/Puncture

  MAUDE report 50820380 ↗
• MalfunctionSep 9, 2026Activation Failure

  It was reported that "a nurse got stuck by the needle because the safety part didn't stay closed on the needle right."

  Patient problems: Needle Stick/Puncture

  MAUDE report 50692095 ↗
• MalfunctionAug 3, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  WE ARE HAVING AN ISSUE WITH THE 0.5 INSULIN NEEDLES. WHEN THEY ARE PUTTING IT IN THE BOTTLE AND OR TAKING IT OUT THEY ARE BENDING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19901174 ↗
• MalfunctionJul 26, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  THE REPORTING FACILITY INDICATED THAT THE SAFETY MECHANISM OF NEEDLE DOES NOT "READILY ENGAGE IN SUCH A WAY THAT THE NEEDLE REMAINS SECURE." 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.NO SAMPLE AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19835127 ↗
• MalfunctionJul 26, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  THE REPORTING FACILITY INDICATED THAT ISSUES WERE IDENTIFIED WITH THE NEEDLE BENDING. 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-UPCARE, OR OTHER ADVERSE HEALTH IMPACT ASSOCIATED WITH THE REPORTED PROBLEM/ISSUE. NO SAMPLES AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19835010 ↗
• MalfunctionJul 26, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  THE REPORTING FACILITY INDICATED THAT ISSUES WERE IDENTIFIED WITH THE NEEDLE BENDING. 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-UPCARE, OR OTHER ADVERSE HEALTH IMPACT ASSOCIATED WITH THE REPORTED PROBLEM/ISSUE. NO SAMPLES AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19834999 ↗
• MalfunctionJul 26, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  THE INITIAL REPORTER INDICATED THAT A NEEDLE DETACHED FROM THE SYRINGE WHEN THE NEEDLE WAS BEING PULLED OUT FOLLOWING AN INJECTION. THE NEEDLE WAS REPORTEDLY PULLED OUT OF THE PATIENT AND AN X-RAY WAS OBTAINED WHICH CONFIRMED THAT NO NEEDLE FRAGMENT WAS RETAINED WITHIN THE PATIENT. THE DEVICE WAS DISCARDED. NO SERIOUS INJURY OR ADVERSE IMPACT TO A PATIENT OR TO A USER WAS ORIGINALLY REPORTED. 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 PROBLEMS/ISSUES. NO SAMPLE AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19834866 ↗
• MalfunctionJul 26, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT AFTER DRAWING UP INSULIN INTO THE SYRINGE, "THE VIAL WOULD SUCK THE MEDICINE BACK DOWN INTO THE VIAL." THE REPORTING FACILITY ALSO INDICATED THAT LEAKAGE OF INSULIN WAS NOTED WHENEVER FILLED SYRINGES WERE TRANSPORTED USING THE FACILITY'S PRESSURIZED TUBE VACUUM SYSTEM. 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. NO SAMPLE AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19834863 ↗
• MalfunctionJul 26, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  ACCORDING TO THE FACILITY ON (B)(6)2022 A REGISTERED NURSE WAS WIPING THE ARM OF A PATIENT WHEN THEY WERE STUCK' BY A RETAINED NEEDLE IN THE PATIENT'S RIGHT UPPER ARM. PER THE FACILITY NO SERIOUS INJURY WAS REPORTED OTHER THAN A SMALL PUNCTURE FROM THE NEEDLE. THE NURSE WAS SENT TO THE FACILITIES OCCUPATIONAL HEALTH AND A ROUTINE BLOOD DRAW WAS PERFORMED, AND THE EMPLOYEE IS CURRENTLY BACK AT WORK WITHOUT MEDICAL INTERVENTION BEING REQUIRED. NO SAMPLE AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19834850 ↗
• MalfunctionJul 26, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  THE INITIAL REPORTER INDICATED THAT THE SYRINGE VOLUME MARKINGS HAD A "DISTORTED VIEW." ADDITIONALLY, THE REPORTING FACILITY INDICATED THAT THE SAFETY MECHANISM OF THE NEEDLE WAS NOT LOCKING. NO SERIOUS INJURY OR ADVERSE IMPACT TO A PATIENT OR A USER WAS ORIGINALLY REPORTED.NO SAMPLE AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19834761 ↗
• MalfunctionApr 1, 2024Device Markings/Labelling Problem; Protective Measures Problem; Device Markings/Labelling Problem; Protective Measures Problem

  IT WAS REPORTED THAT THE SYRINGE VOLUME MARKINGS HAD A "DISTORTED VIEW."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19016241 ↗
• MalfunctionMar 31, 2024Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT THE SYRINGE CAPS ARE "FLIMSY."

  Patient problems: Needle Stick/Puncture

  MAUDE report 19009243 ↗
• MalfunctionMar 25, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT A NEEDLE DETACHED FROM THE SYRINGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18968793 ↗
• MalfunctionMar 8, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT MEDICATION DRAWN INTO THE SYRINGE WOULD RETURN TO THE VIAL AND THAT IT LEAKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18865318 ↗