Port Access Needle LH-0039Recalls & reported problems
Bard Access Systems, Inc. · SafeStep 19G x 0.5 inch · Class 2
All models of Port Access Needle (122)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00801741066368), received between Aug 20, 2024 and Aug 21, 2024 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (5 reports).
1 FDA recall record name this device's identifier.
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.
Reports received per month
Recalls naming this device
- Jun 19, 2020Class IITerminated
Potential development of cracks or breaks in the tubing near the Luer or Y site of the device. Devices that have developed breaks or cracks can cause leakage resulting in exposure to chemicals such a chemotherapeutics or biohazard material (e.g., blood). A crack or break could result in potential blood loss, catheter occlusion, air embolism, under or interrupted infusion, or site contamination which could lead to infection.
Z-2671-2020 · Root cause: Process control · Recall details · FDA record ↗
Most reported problems
Device problems
- Fluid/Blood Leak5
Patient problems
- No Clinical Signs, Symptoms or Conditions5
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 21, 2024Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED EXTENSION BREAKS DURING USAGE CAUSING LEAKING OF CHEMOTHERAPY AND BIOLOGICAL FLUIDS. OCCURRED DURING USE. NURSES HAVE FOUND SEVERAL PORT NEEDLE EXTENSIONS BROKEN DURING INFUSION IN PEDIATRIC PATIENTS OF AROUND 4-5 YEARS OLD. THIS CAUSES LEAKAGE OF CHEMOTHERAPY AND BIOLOGICAL FLUIDS. IT HAS BEEN NECESSARY TO REMOVE THE NEEDLE AND PRICK THE RESERVOIR WITH A NEW ONE TO CONTINUE WITH THE TREATMENT. EXPOSURE TO BLOOD AND CYTOTOXICS. IT WAS REPORTED THIS OCCURRED WITH 5 DEVICES. THIS REPORT ADDRESSES THE SECOND DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20023369 ↗MalfunctionAug 21, 2024Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED EXTENSION BREAKS DURING USAGE CAUSING LEAKING OF CHEMOTHERAPY AND BIOLOGICAL FLUIDS. OCCURRED DURING USE. NURSES HAVE FOUND SEVERAL PORT NEEDLE EXTENSIONS BROKEN DURING INFUSION IN PEDIATRIC PATIENTS OF AROUND 4-5 YEARS OLD. THIS CAUSES LEAKAGE OF CHEMOTHERAPY AND BIOLOGICAL FLUIDS. IT HAS BEEN NECESSARY TO REMOVE THE NEEDLE AND PRICK THE RESERVOIR WITH A NEW ONE TO CONTINUE WITH THE TREATMENT. EXPOSURE TO BLOOD AND CYTOTOXICS. IT WAS REPORTED THIS OCCURRED WITH 5 DEVICES. THIS REPORT ADDRESSES THE THIRD DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20017299 ↗MalfunctionAug 20, 2024Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED EXTENSION BREAKS DURING USAGE CAUSING LEAKING OF CHEMOTHERAPY AND BIOLOGICAL FLUIDS. OCCURRED DURING USE. NURSES HAVE FOUND SEVERAL PORT NEEDLE EXTENSIONS BROKEN DURING INFUSION IN PEDIATRIC PATIENTS OF AROUND 4-5 YEARS OLD. THIS CAUSES LEAKAGE OF CHEMOTHERAPY AND BIOLOGICAL FLUIDS. IT HAS BEEN NECESSARY TO REMOVE THE NEEDLE AND PRICK THE RESERVOIR WITH A NEW ONE TO CONTINUE WITH THE TREATMENT. EXPOSURE TO BLOOD AND CYTOTOXICS. IT WAS REPORTED THIS OCCURRED WITH 5 DEVICES. THIS REPORT ADDRESSES THE FIRST DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20008361 ↗MalfunctionAug 20, 2024Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED EXTENSION BREAKS DURING USAGE CAUSING LEAKING OF CHEMOTHERAPY AND BIOLOGICAL FLUIDS. OCCURRED DURING USE. NURSES HAVE FOUND SEVERAL PORT NEEDLE EXTENSIONS BROKEN DURING INFUSION IN PEDIATRIC PATIENTS OF AROUND 4-5 YEARS OLD. THIS CAUSES LEAKAGE OF CHEMOTHERAPY AND BIOLOGICAL FLUIDS. IT HAS BEEN NECESSARY TO REMOVE THE NEEDLE AND PRICK THE RESERVOIR WITH A NEW ONE TO CONTINUE WITH THE TREATMENT. EXPOSURE TO BLOOD AND CYTOTOXICS. IT WAS REPORTED THIS OCCURRED WITH 5 DEVICES. THIS REPORT ADDRESSES THE FOURTH DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20008071 ↗MalfunctionAug 20, 2024Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED EXTENSION BREAKS DURING USAGE CAUSING LEAKING OF CHEMOTHERAPY AND BIOLOGICAL FLUIDS. OCCURRED DURING USE. NURSES HAVE FOUND SEVERAL PORT NEEDLE EXTENSIONS BROKEN DURING INFUSION IN PEDIATRIC PATIENTS OF AROUND 4-5 YEARS OLD. THIS CAUSES LEAKAGE OF CHEMOTHERAPY AND BIOLOGICAL FLUIDS. IT HAS BEEN NECESSARY TO REMOVE THE NEEDLE AND PRICK THE RESERVOIR WITH A NEW ONE TO CONTINUE WITH THE TREATMENT. EXPOSURE TO BLOOD AND CYTOTOXICS. IT WAS REPORTED THIS OCCURRED WITH 5 DEVICES. THIS REPORT ADDRESSES THE FIFTH DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20003803 ↗
Other Set, administration, intravascular devices
- Autosoft XC 1001680Unomedical A/S · Set, Administration, Intravascular1 death16,105 reports
- Autosoft90™ 1002817Unomedical A/S · Set, Administration, Intravascular1 recall11,907 reports
- Minimed™ Quick-set™ MMT-399AUnomedical A/S · Set, Administration, Intravascular9 deaths8,669 reports
- Medtronic Extended MMT-431AUnomedical A/S · Set, Administration, Intravascular3 deaths8,574 reports
- MiniMed™ Mio™ Advance MMT-242AUnomedical A/S · Set, Administration, Intravascular15 deaths8,164 reports
- CADD 21-7302-24Icu Medical, Inc. · Set, administration, intravascular4 recalls1 death4,657 reports
- Autosoft XC 1001681Unomedical A/S · Set, Administration, Intravascular1 death4,216 reports
- Minimed™ Quick-set™ MMT-397AUnomedical A/S · Set, Administration, Intravascular19 deaths4,134 reports
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 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page