Port Access Needle LH-0034YNRecalls & reported problems
Bard Access Systems, Inc. · SafeStep 19G x 1 inch with y-site · Class 2
All models of Port Access Needle (122)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 9
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00801741066276), received between Sep 13, 2019 and Nov 18, 2025 — classified as 9 malfunctions.
The most frequently reported specific device problem is “Material Deformation” (6 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 16, 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
- Material Deformation6
- Contamination /Decontamination Problem5
- Fluid/Blood Leak2
- Break1
- Leak/Splash1
Patient problems
- No Clinical Signs, Symptoms or Conditions7
- Chemical Exposure2
Recent adverse event reports
The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 18, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED NON POWER PORTS LEAKING AT THE NEEDLESS CONNECTOR. THERE HAS NOT BEEN ANY REPORTED PATIENT HARM OR BAD OUTCOME FROM THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23584400 ↗MalfunctionApr 2, 2025Break; Material Deformation; Break; Material Deformation
THE CUSTOMER RETURNED FOUR DEVICES TO THE MANUFACTURER AND ALL FOUR WERE FOUND TO HAVE PLASTIC BROKE OFF THE END CAPS. THIS REPORT ADDRESSES ALL FOUR DEVICES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21754127 ↗MalfunctionFeb 5, 2025Contamination /Decontamination Problem; Material Deformation; Contamination /Decontamination Problem; Material Deformation
IT WAS REPORTED THAT THE NEEDLE HAS A SMALL PIECE OF PLASTIC HAS BROKEN OFF THE END WHITE CAP THAT IS ATTACHED INTO THE FEMALE HUB OF THE NEEDLE RESULTING IN A FOREIGN BODY WITHIN THE HUB. THIS SHOULD NOT BE THERE. THIS CAP SHOULD BE REMOVED INTACT WITH A HUB FREE OF A FOREIGN BODY. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21316070 ↗MalfunctionJan 3, 2025Contamination /Decontamination Problem; Material Deformation; Contamination /Decontamination Problem; Material Deformation
IT WAS REPORTED THAT THE CUSTOMER IS SEEING A PIECE OF THE END CAP SHAVING OFF AND FALLING INTO THE NEEDLE LUER UPON REMOVAL. THERE WAS NO HARM, INJURY, COMPLICATIONS OR UNPLANNED MEDICAL INTERVENTION REQUIRED. THIS SITUATION DID CAUSE A MINIMAL DELAY IN PATIENT TREATMENT AS THE NURSE NEEDED TO OBTAIN ANOTHER HUBER NEEDLE. NO OTHER INFORMATION PROVIDED, AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21068768 ↗MalfunctionJan 2, 2025Contamination /Decontamination Problem; Material Deformation; Contamination /Decontamination Problem; Material Deformation
IT WAS REPORTED THAT A 1 INCH HUBER NEEDLE CONTAINS LOOSE PLASTIC AND IS PRESENTS WHEN TWISTING OFF THE CAP. THE ISSUE WAS INTERCEPTED PRIOR TO USE ON A PATIENT. NO OTHER INFORMATION PROVIDED, AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21061325 ↗MalfunctionDec 31, 2024Contamination /Decontamination Problem; Material Deformation; Contamination /Decontamination Problem; Material Deformation
IT WAS REPORTED, "AFTER LUNCH TODAY ONE OF MY STAFF FOUND 2 1INCH NEEDLES LOT# ASJQFC044 WITH SMALL SHARDS OF PLASTIC. I LOOKED AT THEM CLOSER AND IT SEEMS AS IF THE PIECE OF PLASTIC IS BREAKING OFF THE CAP. I ALSO HAVE THE CAPS ON THE NEEDLES WITH THE SHARD IN THE FEMALE END OF THE TUBING. NO ADVERSE EVENTS OR INJURY OCCURRED REGARDING THIS ISSUE." NO OTHER INFORMATION WAS PROVIDED. IT WAS REPORTED THIS OCCURRED WITH TWO DEVICES. THIS REPORT ADDRESSES BOTH DEVICES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21050570 ↗MalfunctionDec 31, 2024Contamination /Decontamination Problem; Material Deformation; Contamination /Decontamination Problem; Material Deformation
IT WAS REPORTED THAT SMALL SHARDS OF PLASTIC IS BREAKING OFF THE CAP. NO ADVERSE EVENTS OR INJURY OCCURRED REGARDING THIS ISSUE. NO OTHER INFORMATION PROVIDED, AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21047629 ↗MalfunctionSep 13, 2019Fluid/Blood Leak
IT WAS REPORTED THAT THE ANTI-REFLUX VALVE LEAKED. THE PATIENT HAD PRODUCT ON HER ARM. THE TEAM HAD TO DECONTAMINATE IT. IT WAS STATED THAT THIS EVENT OCCURRED WITH TWO PATIENTS. THIS REPORT ADDRESSES THE FIRST PATIENT.
Patient problems: Chemical Exposure
MAUDE report 9035905 ↗MalfunctionSep 13, 2019Leak/Splash
IT WAS REPORTED THAT THE ANTI-REFLUX VALVE LEAKED. THE PATIENT HAD PRODUCT ON HER ARM. THE TEAM HAD TO DECONTAMINATE IT. IT WAS STATED THAT THIS EVENT OCCURRED WITH TWO PATIENTS. THIS REPORT ADDRESSES THE SECOND PATIENT.
Patient problems: Chemical Exposure
MAUDE report 9035866 ↗
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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 13, 2026 · each recall links to the FDA recall notice
- 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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