Port Access Needle LH-0031YNRecalls & reported problems
Bard Access Systems, Inc. · SafeStep 20G x 0.75 inch with y-site · Class 2
All models of Port Access Needle (122)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Bard SafeStep port access needle set delivers fluids and medicines into a port placed under the skin. Many of its 286 reports describe fluid or blood leaking from the needleless connector, sometimes spraying during flushing and exposing staff. The reports include 3 injuries and no deaths. One closed recall began in June 2020 and concerned cracks or breaks in tubing near the connector, which could cause leaks.
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
- 287
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 287 adverse event reports that list this exact device (DI 00801741066214), received between May 9, 2018 and Sep 23, 2026 — classified as 3 injuries, 284 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (138 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-2669-2020 · Root cause: Process control · Recall details · FDA record ↗
Most reported problems
Device problems
- Fluid/Blood Leak138
- Leak/Splash52
- Activation Problem43
- Crack15
- Material Deformation14
- Detachment of Device or Device Component9
- Component Missing8
- Misassembled8
Patient problems
- No Clinical Signs, Symptoms or Conditions135
- No Known Impact Or Consequence To Patient82
- No Consequences Or Impact To Patient46
- Needle Stick/Puncture8
- No Patient Involvement6
- Exposure to Body Fluids4
- No Information4
- Chemical Exposure3
Recent adverse event reports
The 25 most recent of 287 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 23, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50863112 ↗MalfunctionSep 16, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50791398 ↗MalfunctionMay 27, 2026Fluid/Blood Leak
IT WAS REPORTED LEAKING FROM THE NEEDLESS CONNECTOR. PRODUCT WAS USED ON THE PATIENT. LEAK WAS FOUND WHEN GIVING NORMAL SALINE. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25302444 ↗MalfunctionMay 27, 2026Fluid/Blood Leak
IT WAS REPORTED LEAKING FROM THE NEEDLESS CONNECTOR. NO PATIENT INVOLVEMENT. IT WAS REPORTED THIS OCCURRED WITH TWO DEVICES. THIS REPORT ADDRESSES BOTH DEVICES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25301837 ↗MalfunctionMay 19, 2026Fluid/Blood Leak
IT WAS REPORTED AT THE Y OF THE TUBING: THE WHITE TIP WAS INCORRECTLY SCREWED IN AND THIS CREATED A FLOW OF SOLUTE. THE NEEDLE WAS IN PLACE ON THE PATIENT AND THE FLUID WITH NACL IN PROGRESS; THE PATIENT SUBSEQUENTLY HAD A CHEMO SCAN. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25219150 ↗MalfunctionMay 19, 2026Fluid/Blood Leak
IT WAS REPORTED BY CUSTOMER THAT THE SALINE SPRAYING FROM THE NEEDLESS CONNECTOR Y-SITE DURING FLUSHING. BLOOD EXPOSURE OCCURRED. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25218588 ↗MalfunctionMay 11, 2026Fluid/Blood Leak
IT WAS REPORTED THAT THE PROXIMAL Y-SITE PORT LEAKING BLOOD/FLUID AFTER LAB DRAWS/FLUSHING. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25136708 ↗MalfunctionMay 8, 2026Fluid/Blood Leak
IT WAS REPORTED, SALINE SPRAYING FROM THE NEEDLESS CONNECTOR Y-SITE DURING FLUSHING. WE HAVE HAD THIS OCCUR MORE THAN ONCE. ADDITIONAL INFORMATION RECEIVED: THE MATERIAL WAS THE SAFESTEP HUBER NEEDLE SET. THERE WAS NO HARM TO THE PATIENT BUT WHEN THE NURSE FLUSHED, BLOOD SHOT OUT FROM THE SECONDARY PORT AND EXPOSED HER AND THE PATIENT TO BLOOD. THERE WAS NO CONTACT WITH MUCOUS MEMBRANES (EYES, NOSE, OR MOUTH) OR OPEN SKIN. IN ALL INSTANCES, THE PATIENT¿S BLOOD CONTACTED THE NURSE¿S CLOTHING ONLY. NO LABS OR PROPHYLACTIC TREATMENT WERE INDICATED. THERE IS NO KNOWN DOCUMENTATION INDICATING THE PATIENT HAS A BLOODBORNE PATHOGEN. A SPECIFIC NUMBER OF AFFECTED DEVICES OR PATIENTS WAS NOT PROVIDED BY THE COMPLAINANT. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: Exposure to Body Fluids
MAUDE report 25124110 ↗MalfunctionMay 6, 2026Fluid/Blood Leak
IT WAS REPORTED, SALINE SPRAYING FROM THE NEEDLESS CONNECTOR Y-SITE DURING FLUSHING. WE HAVE HAD THIS OCCUR MORE THAN ONCE. ADDITIONAL INFORMATION RECEIVED: THE MATERIAL WAS THE SAFESTEP HUBER NEEDLE SET. THERE WAS NO HARM TO THE PATIENT BUT WHEN THE NURSE FLUSHED, BLOOD SHOT OUT FROM THE SECONDARY PORT AND EXPOSED HER AND THE PATIENT TO BLOOD. THERE WAS NO CONTACT WITH MUCOUS MEMBRANES (EYES, NOSE, OR MOUTH) OR OPEN SKIN. IN ALL INSTANCES, THE PATIENT¿S BLOOD CONTACTED THE NURSE¿S CLOTHING ONLY. NO LABS OR PROPHYLACTIC TREATMENT WERE INDICATED. THERE IS NO KNOWN DOCUMENTATION INDICATING THE PATIENT HAS A BLOODBORNE PATHOGEN. A SPECIFIC NUMBER OF AFFECTED DEVICES OR PATIENTS WAS NOT PROVIDED BY THE COMPLAINANT. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: Exposure to Body Fluids
MAUDE report 25104494 ↗MalfunctionApr 20, 2026Fluid/Blood Leak
IT WAS REPORTED BY CUSTOMER THAT BD SAFESTEP PORT NEEDLE, RN ACCESSED PORT AND OBTAINED BLOOD SAMPLE THROUGH DISTAL PORT, WHEN FLUSHING LINE THROUGH DISTAL PORT, BLOOD/FLUID LEAKING OUT OF PROXIMAL PORT. NO KNOWN HARM TO PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24927311 ↗MalfunctionApr 13, 2026Fluid/Blood Leak; Material Deformation
IT WAS REPORTED DURING BLOOD WITHDRAWAL, THE NURSE NOTED ASPIRATION OF AIR. AFTER REINSERTION, LEAKAGE WAS OBSERVED. NO PATIENT INJURY WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24866209 ↗MalfunctionApr 2, 2026Fluid/Blood Leak
IT WAS REPORTED A CRACK AND LEAKAGE. THE HOSPITAL WINDOW STAFF STATED THAT LIQUID LEAKAGE OCCURRED DURING USE, BUT THEY WERE UNSURE OF THE EXACT LOCATION. THE PATIENT WAS NOT INJURED. THE PROCEDURE WAS SUBSEQUENTLY PERFORMED USING A NEW NEEDLE. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24769037 ↗MalfunctionMar 10, 2026Fluid/Blood Leak
IT WAS REPORTED THAT THE NURSE POSITIONED THE PORT-A NEEDLE PROPERLY. WHEN PREPARING TO DRAW BLOOD, ONLY AIR WAS ASPIRATED AND NO BLOOD RETURN WAS OBTAINED. AFTER REMOVING THE NEEDLE FOR INSPECTION, IT WAS FOUND THAT FLUID WAS LEAKING AT THE MEDICAL DEVICE CONNECTION. IT WAS REPORTED THIS OCCURRED WITH TWO DEVICES. THIS REPORT ADDRESSES BOTH DEVICES. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24565433 ↗MalfunctionMar 3, 2026Activation Problem
IT WAS REPORTED BY THE CUSTOMER THAT THE SAFETY MECHANISM IS DIFFICULT TO ADVANCE OFF THE NEEDLE HUB. IT WAS REPORTED THIS OCCURRED WITH TWELVE DEVICES. THIS REPORT ADDRESSES ALL TWELVE DEVICES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24498061 ↗MalfunctionFeb 17, 2026Fluid/Blood Leak
IT WAS REPORTED THE NURSE POSITIONED THE PORT-A NEEDLE PROPERLY. WHEN PREPARING TO DRAW BLOOD, ONLY AIR WAS ASPIRATED AND NO BLOOD RETURN WAS OBTAINED. AFTER REMOVING THE NEEDLE FOR INSPECTION, IT WAS FOUND THAT FLUID WAS LEAKING AT THE MEDICAL DEVICE CONNECTION. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24366427 ↗MalfunctionFeb 6, 2026Fluid/Blood Leak
IT WAS REPORTED THAT THE NURSE POSITIONED THE PORT-A NEEDLE PROPERLY. WHEN PREPARING TO DRAW BLOOD, ONLY AIR WAS ASPIRATED AND NO BLOOD RETURN WAS OBTAINED. AFTER REMOVING THE NEEDLE FOR INSPECTION, IT WAS FOUND THAT FLUID WAS LEAKING AT THE MEDICAL DEVICE CONNECTION. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24283393 ↗MalfunctionJan 29, 2026Crack
IT WAS REPORTED THAT THE NEEDLE-FREE CONNECTOR IS CRACKED AND LEAKING. NO FURTHER DETAILS AVAILABLE OR PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24208719 ↗MalfunctionJan 8, 2026Activation Problem
IT WAS REPORTED THE CHASSIS CANNOT BE PUSHED DOWNWARD SMOOTHLY, AND THERE IS A SENSE OF RESISTANCE DURING STARTUP. THE TESTING WAS CONDUCTED BY THE BUSINESS TEAM, WITH NO PATIENT INVOLVEMENT. IT WAS REPORTED THIS OCCURRED WITH THREE DEVICES. THIS REPORT ADDRESSES ALL THREE DEVICES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24002480 ↗MalfunctionDec 30, 2025Activation Problem; Activation Problem
IT WAS REPORTED THAT THE RESISTANCE IS GREAT WHEN REMOVING THE SAFESTEP, IT IS DIFFICULT TO REMOVE AND REQUIRES A LOT OF FORCE. AFTER PULLING IT OUT, THE NEEDLE SEPARATES FROM THE DISC. NO FURTHER INFORMATION PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23931390 ↗MalfunctionDec 11, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT LEAKING FROM THE NEEDLESS CONNECTOR. PROCEDURE WAS COMPLETED WITH ANOTHER PORT NEEDLE. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23778266 ↗MalfunctionNov 19, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED BY THE CUSTOMER THAT THE SAFESTEP HUBER NEEDLE WAS LEAKING AT THE MEDEGEN Y-SITE ONCE A NEEDLEFREE CONNECTOR WAS ATTACHED. IT WAS REPORTED THIS OCCURRED WITH ONE DEVICE AND DID NOT HAPPEN IMMEDIATELY BUT ON DAY 2 OR 3 OF USE. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23597633 ↗MalfunctionOct 15, 2025Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak
IT WAS REPORTED LEAKAGE HAS OCCURRED DUE TO DAMAGE IN THE DEEDLESS Y-SITE AREA. THE EVENT OCCURRED DURING FLUSHING PRIOR TO USE ON A PATIENT. THE PORT WAS ACCESSED WITH A NEW NEEDLE. NO HARM WAS CAUSED TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23293139 ↗MalfunctionSep 23, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED LEAKING FROM THE HOUSING. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23127242 ↗MalfunctionAug 13, 2025Defective Component; Defective Component
IT WAS REPORTED THAT FEMALE LUER HUB ID WAS OUT OF SPEC.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22793709 ↗MalfunctionJul 30, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED BY THE CUSTOMER THAT THE PORT IN BETWEEN THE CLAMP ON THE IVAD ACCESS NEEDLE WAS LEAKING DURING A BLOOD DRAW PROCEDURE. THIS LED TO ADDITIONAL UNEXPECTED TESTING, CARE, AND A DELAY IN TREATMENT/THERAPY. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22667879 ↗
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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 · 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.
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