Port Access Needle LH-0029YNRecalls & reported problems
Bard Access Systems, Inc. · SafeStep 22G 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 is a needle set used to give fluids and medicine through an implanted port. Many of the 178 reports describe fluid leaking from the tubing or connection points, tubing breaking or cracking, and safety mechanisms that did not activate. The reports include 178 malfunctions, no injuries and no deaths. One recall, started in June 2020 and now closed, concerns tubing that may crack or break near the connection points, which can 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
- 177
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 177 adverse event reports that list this exact device (DI 00801741066177), received between May 17, 2018 and Jun 9, 2026 — classified as 177 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (94 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 Leak94
- Activation Problem29
- Material Twisted/Bent23
- Defective Component13
- Crack12
- Leak/Splash11
- Break6
- Material Deformation6
Patient problems
- No Clinical Signs, Symptoms or Conditions107
- No Consequences Or Impact To Patient39
- No Patient Involvement15
- No Known Impact Or Consequence To Patient14
- Chemical Exposure3
- No Information3
- Skin Inflammation/ Irritation2
- Exposure to Body Fluids1
Recent adverse event reports
The 25 most recent of 177 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 9, 2026Fluid/Blood Leak
IT WAS REPORTED ANYTHING INFUSED WOULD BE LEAKED AND NOT ACTUALLY INFUSED INTO THE PATIENT AS ORDERED. THE LEAK WAS DISCOVERED WHEN THE PATIENT NOTICED HER DRESSING AND ARM WAS WET, SHE CALLED AND CAME INTO CLINIC FOR ASSESSMENT. FORTUNATELY THE PATIENT DID NOT SEEM TO HAVE ANY ADVERSE SKIN REACTION. SHE WILL HAVE MISSED A SMALL AMOUNT OF HER DOSE, IT IS UNLIKELY TO NEGATIVELY IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25444404 ↗MalfunctionApr 15, 2026Fluid/Blood Leak
IT WAS REPORTED THAT LEAKING IV PORT NEEDLE LINE AT THE NEEDLELESS INJECTION Y-SITE THAT WAS BEING USED TO DELIVER CHEMOTHERAPY. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24888898 ↗MalfunctionApr 3, 2026Fluid/Blood Leak
IT WAS REPORTED THAT PORT NEEDLE TUBING IS BREAKING ABOVE THE HUB. PATIENT HAD TO BE RE-ACCESSED. ADDITIONAL INFORMATION: PATIENT EXPERIENCED SOME BLOOD LOSS. PATIENT HAD DELAY AND INTERRUPTION OF CHEMO AND FLUIDS. SOME BREAKDOWN OF SKIN FROM MULTIPLE DRESSING CHANGES. THE LINE ALSO NEEDED TO HAVE TPA INSTILLED AT LEAST ONCE DUE TO CLOTTING OFF. PATIENT IS CURRENTLY AT HOME RECEIVING BLINATUMOMAB AND WE HAD TO START A PICC LINE.
Patient problems: Skin Inflammation/ Irritation
MAUDE report 24778227 ↗MalfunctionApr 2, 2026Fluid/Blood Leak
IT WAS REPORTED THAT THE NEEDLE TUBING IS BREAKING ABOVE THE HUB. ADDITIONAL INFORMATION RECEIVED: SHE IS A 1 YEAR OLD THAT NEEDED RE-ACCESSED AFTER EACH NEEDLE BREAK. SHE EXPERIENCED SOME BLOOD LOSS (SOME MORE THAN OTHERS) DEPENDING ON WHEN THE BREAK WAS CAUGHT. SHE HAD DELAYS AND INTERRUPTIONS OF CHEMO AND FLUIDS. SOME BREAKDOWNS OF SKIN FROM MULTIPLE DRESSING CHANGES. HER LINE ALSO NEEDED TO HAVE TPA INSTILLED AT LEAST ONCE DUE TO CLOTTING OFF. SHE IS CURRENTLY AT HOME RECEIVING BLINATUMOMAB AND WE HAD TO START A PICC LINE BECAUSE WE COULDN'T TRUST THAT HER NEEDLE WOULDN'T BREAK AT HOME DURING THE MONTH-LONG INFUSION (NEEDLE CHANGES EVERY 7 DAYS). IF THE DRUG IS DELAYED DUE TO DISCONNECTION OR BREAKAGE OF LINE FOR MORE THAN 4 HOURS THE PATIENT WOULD HAVE TO BE READMITTED FOR CLOSER MONITORING ON RESTART OF THE DRUG.
Patient problems: Skin Inflammation/ Irritation
MAUDE report 24769716 ↗MalfunctionMar 9, 2026Activation Problem
IT WAS REPORTED AFTER USE, THE SAFETY MECHANISM TO PREVENT NEEDLE STICKS DID NOT ACTIVATE. THERE WAS NO REPORTED PATIENT INJURY. NO NEEDLE STICK INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24547088 ↗MalfunctionFeb 18, 2026Material Twisted/Bent; Activation Problem
IT WAS REPORTED THAT THE SAFETY MECHANISM DID NOT ACTIVATE WHEN THE NEEDLE WAS WITHDRAWN. THERE WAS NO REPORTED PATIENT INJURY. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24384162 ↗MalfunctionNov 14, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED BY THE CUSTOMER THAT WHEN PERFORMING A CVAD FLUSH WRITER NOTED FLUID LEAKING FROM THE BLUE VALVE OF THE NEEDLELESS INJECTION Y-SITE OF HUBER NEEDLE SET. NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23555794 ↗MalfunctionNov 13, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT THERE WAS LEAKAGE HAPPENED IN MEDEGEN NEEDLELESS INJECTION CAP IN SAFESTEP HUBER NEEDLE SET LH-0029YN DURING FLUSHING. THE FLUSHING SALINE WAS BACK FLOW IN NEEDLELESS INJECTION CAP. ADDITIONAL UNOPENED SAMPLES WERE RECEIVED. DURING FUNCTIONAL TESTING, A DROPLET OF FLUID WAS NOTED ON THE VALVED Y-SITE. IT WAS REPORTED THIS OCCURRED WITH 5 DEVICES. THIS REPORT ADDRESSES ALL 5 DEVICES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23543899 ↗MalfunctionNov 4, 2025Misassembled; Misassembled
IT WAS REPORTED SINCE THE NEEDLE TIP PROTECTION COVER WAS NOT INCLUDED FROM THE BEGINNING, WE STOPPED USING IT. WE RETURNED IT AFTER THE NEEDLE TIP PROTECTION MECHANISM WAS ACTIVATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23468134 ↗MalfunctionOct 15, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED, IV FLUID/CHEMOTHERAPY HAD LEAKED AT THE CONNECTION POINT LOCATED BETWEEN THE TWO CLAMPS. NO PATIENT INJURY OBSERVED. MINUTE LEAKING OF CHEMOTHERAPY (FLUOROURACIL) AT Y CONNECTION SITE, WHICH IS THE PROBLEM AREA. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23295340 ↗MalfunctionOct 15, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED, IV FLUID/CHEMOTHERAPY HAD LEAKED AT THE CONNECTION POINT LOCATED BETWEEN THE TWO CLAMPS. NO PATIENT INJURY OBSERVED. MINUTE LEAKING OF CHEMOTHERAPY (FLUOROURACIL) AT Y CONNECTION SITE, WHICH IS THE PROBLEM AREA. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23295040 ↗MalfunctionOct 15, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED, IV FLUID/CHEMOTHERAPY HAD LEAKED AT THE CONNECTION POINT LOCATED BETWEEN THE TWO CLAMPS. NO PATIENT INJURY OBSERVED. MINUTE LEAKING OF CHEMOTHERAPY (FLUOROURACIL) AT Y CONNECTION SITE, WHICH IS THE PROBLEM AREA. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23294748 ↗MalfunctionOct 15, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED, IV FLUID/CHEMOTHERAPY HAD LEAKED AT THE CONNECTION POINT LOCATED BETWEEN THE TWO CLAMPS. NO PATIENT INJURY OBSERVED. MINUTE LEAKING OF CHEMOTHERAPY (FLUOROURACIL) AT Y CONNECTION SITE, WHICH IS THE PROBLEM AREA. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23294359 ↗MalfunctionOct 15, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THERE WAS LEAKAGE HAPPENED IN MEDEGEN NEEDLELESS INJECTION CAP IN SAFESTEP HUBER NEEDLE SET LH-0029YN DURING FLUSHING. THE FLUSHING SALINE WAS BACK FLOW IN NEEDLELESS INJECTION CAP. THE PATIENT WAS NOT HARMED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23286690 ↗MalfunctionAug 12, 2025Material Twisted/Bent; Activation Problem; Material Twisted/Bent; Activation Problem
IT WAS REPORTED THAT THE SAFETY MECHANISM DID NOT WORK WHEN THE NEEDLE WAS REMOVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22787114 ↗MalfunctionJul 3, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT LEAKING FROM Y SITE WHEN SALINE LOCKED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22398216 ↗MalfunctionApr 3, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT WHEN CHECKING FOR BACKFLOW, AIR CAME OUT ALONG WITH THE BLOOD. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21763274 ↗MalfunctionMar 13, 2025Material Twisted/Bent; Activation Problem; Material Twisted/Bent; Activation Problem
IT WAS REPORTED THAT THE SAFETY FEATURE DID NOT WORK. PATIENT CAME TO THE HOSPITAL AND ATTEMPTED TO REMOVE THE NEEDLE, BUT THE SAFETY MECHANISM FAILED TO ACTIVATE AND THE NEEDLE WAS REMOVED. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21600541 ↗MalfunctionMar 13, 2025Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak
IT WAS REPORTED THAT A CHEMICAL SOLUTION WAS LEAKING FROM THE CONNECTOR OF THE SIDE TUBE DURING PRIMING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21599439 ↗MalfunctionMar 6, 2025Material Twisted/Bent; Activation Problem; Material Twisted/Bent; Activation Problem
IT WAS REPORTED THAT SAFETY MECHANISM CAN¿T WORK AFTER USE. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21542862 ↗MalfunctionFeb 20, 2025Fluid/Blood Leak; Material Twisted/Bent; Fluid/Blood Leak; Material Twisted/Bent
IT WAS REPORTED THAT THE NEEDLE WAS BROKEN FROM THE START. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21424078 ↗MalfunctionFeb 6, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THERE WAS LEAKAGE AT THE BASE OF THE CANULA INJECTION. NO CLINICAL CONSEQUENCES REPORTED. THE DEVICE WAS USED TO ADMINISTER 0.9% NACL (NORMAL SALINE).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21327488 ↗MalfunctionOct 18, 2024Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT THE NEEDLE LOOKS BENDING AND THERE'S A RESISTANCE WHILE PRIMING THE TUBE. NO OTHER INFORMATION WAS PROVIDED. 09/25/2024 - DURING EVALUATION OF THE RETURNED DEVICE, THE SAFETY MECHANISM WAS FOUND TO BE CRACKED AND UNABLE TO BE ADVANCED OVER THE NEEDLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20484524 ↗MalfunctionOct 10, 2024Material Twisted/Bent; Activation Problem; Material Twisted/Bent; Activation Problem
IT WAS REPORTED THAT SAFETY MECHANISM CAN¿T WORK. OCCURRED AFTER USE. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20418096 ↗MalfunctionSep 19, 2024Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT DURING INFUSION VIA FEMALE LUER CONNECTOR, THE LEAK WAS FOUND ON Y SITE. OCCURRED BEFORE USE, NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20263326 ↗
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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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