Medline SYR101272Recalls & reported problems
Medline Industries, Inc. · SYRINGE, TB,1ML, 27GX 1/2" · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Medline 1 mL tuberculosis syringe with a thin needle is used for drawing up and injecting medication. The 37 adverse event reports mostly describe the needle coming loose from the syringe during an injection, sometimes leaving the needle behind in the patient and causing medication to spill so a full dose is not given, along with leaking and a needle piercing through its cap. There are 7 injuries and no deaths. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 38
- Deaths reported
- 0
- Injuries reported
- 7
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 38 adverse event reports that list this exact device (DI 30080196448818), received between Dec 5, 2019 and Sep 17, 2026 — classified as 7 injuries, 31 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (15 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.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component15
- Insufficient Device Problem Information11
- Fluid/Blood Leak4
- Connection Problem3
- Leak/Splash3
- Appropriate Device Problem Term/Code Not Available2
- Loose or Intermittent Connection2
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions34
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available3
- Needle Stick/Puncture1
Recent adverse event reports
The 25 most recent of 38 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 17, 2026Detachment of Device or Device Component
It was reported that "Subcutaneous injection was being administered with the Tuberculin syringe and during administration the entire hub shot off from the syringe lost half of solution. Re-assessed by using 2 other syringes. Same result."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50803257 ↗MalfunctionJul 26, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS ORIGINALLY REPORTED THAT THE TB NEEDLE WAS DETACHING FROM THE HUB WHILE DRAWING UP AN UNSPECIFIED VACCINE AND THAT IT ALSO DETACHED AND REMAINED IN A CHILD'S LEG DURING VACCINE ADMINISTRATION. DUE TO THE REPORTED INCIDENT, AND IN AN ABUNDANCE OF CAUTION, THIS IS AN MDR REPORTABLE EVENT. NO ADDITIONAL DETAILS AVAILABLE. NO SAMPLES AVAILABLE FOR REVIEW.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19835128 ↗MalfunctionJul 26, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
THE REPORTING FACILITY INDICATED THAT A NEEDLE PIERCED THROUGH A NEEDLE CAP. 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 19835086 ↗MalfunctionJul 26, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
ACCORDING TO THE FACILITY ON (B)(6) 2022 DURING A MEDICATION INJECTION THE NEEDLE BECAME DETACHED FROM THE SYRINGE WHILE IN THE PATIENT AND THE PATIENT DID NOT RECEIVE THE FULL DOSE OF MEDICATION. PER THE FACILITY THE INJECTION WAS INSERTED IN THE PATIENTS RIGHT LOWER QUADRANT OF THE ABDOMEN IN THE PATIENT'S PINCHED ADIPOSE TISSUE'. PER THE FACILITY DURING THE INJECTION WHEN THE PLUNGER WAS DEPRESSED, THE SYRINGE CAME APART FROM THE NEEDLE AND THE MEDICATION EXPLODED OUT OF THE SYRINGE'.NO SAMPLE AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19835045 ↗MalfunctionJul 26, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
ACCORDING TO THE FACILITY ON (B)(6) 2022 DURING A MEDICATION INJECTION THE NEEDLE BECAME DETACHED FROM THE SYRINGE WHILE IN THE PATIENT AND THE PATIENT DID NOT RECEIVE THE FULL DOSE OF MEDICATION. PER THE FACILITY THE INJECTION WAS INSERTED IN THE PATIENTS RIGHT LOWER QUADRANT OF THE ABDOMEN IN THE PATIENT'S PINCHED ADIPOSE TISSUE'. PER THE FACILITY DURING THE INJECTION WHEN THE PLUNGER WAS DEPRESSED, THE SYRINGE CAME APART FROM THE NEEDLE AND THE MEDICATION EXPLODED OUT OF THE SYRINGE'. NO SAMPLE AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19835043 ↗MalfunctionJul 26, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT THE THAT THE NEEDLE DETACHED FROM THE 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. DUE TO THE REPORTED PROBLEM/ISSUE. NO SAMPLES AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19835011 ↗MalfunctionJul 26, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
ACCORDING TO THE FACILITY THE NEEDLE IS DETACHING FROM THE 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. DUE TO THE REPORTED PROBLEM/ISSUE, AND IN AN ABUNDANCE OF CAUTION, AN ADVERSE EVENT REPORT WILL BE FILED. NO SAMPLES AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19835009 ↗MalfunctionJul 26, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
ACCORDING TO THE FACILITY WHEN ADMINISTERING MEDICATION THE "NEEDLE DETACHED FROM THE SYRINGE AND THE PATIENT DOESN'T GET A FULL DOSE OF THE MEDICATION DUE TO THE MEDICATION SPILLING". PER THE FACILITY THIS OCCURRED IN THE PATIENT'S ABDOMEN, AND THE NEEDLE WAS CHECKED FOR SECUREMENT PRIOR TO USE. THE FACILITY STATED THE PATIENT IS DOING OK, AND NO SERIOUS INJURY OCCURRED.NO SAMPLE AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19834932 ↗MalfunctionJul 26, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
THE INITIAL REPORTER INDICATED THAT A NEEDLE DETACHED FROM THE SYRINGE WHEN THE NEEDLE SAFETY CAP WAS REMOVED. 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 SAMPLES AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19834887 ↗MalfunctionJul 26, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
THE INITIAL REPORTER INDICATED THAT A NEEDLE DETACHED FROM THE SYRINGE DURING AN INJECTION OF HEPARIN. THE NEEDLE REMAINED IN THE PATIENT'S ARE FOLLOWING DETACHMENT AND, REPORTEDLY, HEPARIN WENT INTO THE PATIENT AND THE NURSES' EYES. THE NEEDLE WAS REMOVED FROM THE PATIENT. BOTH THE PATIENT AND THE NURSE WERE EVALUATED FOLLOWING THE INCIDENT AND NO SERIOUS INJURY OR ADVERSE IMPACT TO EITHER INDIVIDUAL WAS ORIGINALLY REPORTED. NO SAMPLE AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19834882 ↗MalfunctionJul 26, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
FACILITY REPORTED THAT DURING THE MIDDLE OF MEDICATION INJECTION, ACTUAL MEDICATION NAME NOT REPORTED, THE SYRINGE BECAME DISCONNECTED FROM THE NEEDLE. THE NEEDLE REMAINED IN THE PATIENT AND THE MEDICATION WAS ADMINISTERED AT A REDUCED DOSE. THE NEEDLE WAS SAFELY REMOVED WITHOUT NOTED INJURY. PATIENT WAS DISCHARGED TO A SKILLED NURSING FACILITY. THE SAMPLE WAS PLACED INTO A SHARPS CONTAINER AND WAS UNABLE TO BE RETURNED FOR EVALUATION. NO SAMPLE AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19834769 ↗MalfunctionJul 26, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
THE INITIAL REPORTER INDICATED THAT A NEEDLE DETACHED FROM THE SYRINGE DURING AN INJECTION OF HEPARIN. THE NEEDLE REMAINED IN THE PATIENT'S ARE FOLLOWING DETACHMENT AND, REPORTEDLY, HEPARIN WENT INTO THE PATIENT AND THE NURSES' EYES. THE NEEDLE WAS REMOVED FROM THE PATIENT. BOTH THE PATIENT AND THE NURSE WERE EVALUATED FOLLOWING THE INCIDENT AND NO SERIOUS INJURY OR ADVERSE IMPACT TO EITHER INDIVIDUAL 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 19834767 ↗MalfunctionMay 20, 2024Loose or Intermittent Connection; Loose or Intermittent Connection
FOR NEEDLE DISCONNECTING FROM SYRINGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19349168 ↗MalfunctionApr 10, 2024Connection Problem; Connection Problem
NEEDLE DETACHED WHILE BEING USED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19082328 ↗MalfunctionApr 10, 2024Connection Problem; Connection Problem
MalfunctionApr 10, 2024Incomplete or Inadequate Connection; Incomplete or Inadequate Connection
MalfunctionApr 4, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT NEEDLES ARE "BREAKING OFF" OF THE SYRINGE DURING USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19039053 ↗MalfunctionMar 30, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT WHEN THE NEEDLE CAP WAS REMOVED, THE NEEDLE DETACHED FROM THE SYRINGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19009146 ↗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 18968792 ↗MalfunctionMar 25, 2024Fluid/Blood Leak; Detachment of Device or Device Component; Fluid/Blood Leak; Detachment of Device or Device Component
IT WAS REPORTED THAT A NEEDLE DETACHED FROM THE SYRINGE DURING AN INJECTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18966667 ↗MalfunctionMar 25, 2024Fluid/Blood Leak; Detachment of Device or Device Component; Fluid/Blood Leak; Detachment of Device or Device Component
IT WAS REPORTED THAT A NEEDLE DETACHED FROM THE SYRINGE DURING AN INJECTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18966663 ↗MalfunctionMar 24, 2024Fluid/Blood Leak; Detachment of Device or Device Component; Fluid/Blood Leak; 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 18966557 ↗MalfunctionMar 22, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT A NEEDLE DETACHED FROM THE SYRINGE WHEN THE NEEDLE SAFETY CAP WAS REMOVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18961039 ↗MalfunctionMar 22, 2024Fluid/Blood Leak; Detachment of Device or Device Component; Fluid/Blood Leak; Detachment of Device or Device Component
IT WAS REPORTED THAT A NEEDLE DETACHED FROM THE SYRINGE AND MEDICATION LEAKED OUT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18960358 ↗MalfunctionMar 18, 2024Leak/Splash; Detachment of Device or Device Component; Leak/Splash; Detachment of Device or Device Component
IT WAS REPORTED THAT THE SYRINGE LEAKED AND THAT ITS NEEDLE "STAYED IN PLACE ONCE REMOVED FROM THE INJECTION SITE."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18921998 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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