Port Access Needle LH-0030YNRecalls & reported problems
Bard Access Systems, Inc. · SafeStep 22G x 1 inch with y-site · Class 2
All models of Port Access Needle (122)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 8
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00801741066191), received between Jun 30, 2020 and Feb 18, 2026 — classified as 8 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (4 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 Leak4
- Component Missing2
- Activation Problem1
- Crack1
- Defective Component1
- Misassembled1
- Structural Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions6
- No Consequences Or Impact To Patient3
Recent adverse event reports
The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 18, 2026Activation Problem
IT WAS REPORTED SAFE STEP NEEDLE 22G, 1.0 INCH WAS ATTEMPTED ON PATIENT AND THEN DISCONTINUED FROM PATIENT AS SAFETY MECHANISM DID NOT ACTIVATE. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24383906 ↗MalfunctionMar 1, 2023Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED BY THE CUSTOMER "ACCESSING A PORT-A-CATH AND THE HUBER NEEDLE (SEIZING IT) SEEMED TO HAVE A PROBLEM. AFTER ACCESSING THE PORT-A-CATH, IRRIGATE TO THE DISTAL PORT AND SOME FLUID CAME OUT OF THE PROXIMAL PORT VALVE."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16460681 ↗MalfunctionMar 11, 2022Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT WHEN THE SAFESTEP WAS ACCESSED TO THE PORT BODY AND BLOOD RETURN WAS CONFIRMED, AIR CONTAMINATION WAS FOUND. THEREFORE, THE DEVICE WAS REMOVED. ANOTHER NEEDLE WAS USED TO CONFIRM FOR BLOOD RETURN AFTER ACCESSING TO THE PORT BODY AGAIN, BUT AIR CONTAMINATION WAS FOUND AGAIN. THERE WAS NO REPORTED PATIENT INJURY. THIS REPORT ADDRESSES THE SECOND DEVICE USED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13737032 ↗MalfunctionMar 11, 2022Fluid/Blood Leak; Defective Component; Fluid/Blood Leak; Defective Component
IT WAS REPORTED THAT WHEN THE SAFESTEP WAS ACCESSED TO THE PORT BODY AND BLOOD RETURN WAS CONFIRMED, AIR CONTAMINATION WAS FOUND. THEREFORE, THE DEVICE WAS REMOVED. ANOTHER NEEDLE WAS USED TO CONFIRM FOR BLOOD RETURN AFTER ACCESSING TO THE PORT BODY AGAIN, BUT AIR CONTAMINATION WAS FOUND AGAIN. THERE WAS NO REPORTED PATIENT INJURY. THIS REPORT ADDRESSES THE FIRST DEVICE USED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13736974 ↗MalfunctionJul 1, 2021Component Missing; Component Missing
IT WAS REPORTED THAT WHEN OPENING THE PACKAGE, IT WAS NOTICED THAT THE COVER OF NEEDLE WAS NOT CONTAINED IN IT. THERE WAS NO REPORTED PATIENT INVOLVEMENT. NO OTHER INFORMATION PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12100117 ↗MalfunctionDec 12, 2020Misassembled; Structural Problem; Misassembled
IT WAS REPORTED THAT NEEDLE IS NOT IN THE NEEDLE COVER. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient
MAUDE report 10995384 ↗MalfunctionAug 12, 2020Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak
IT WAS REPORTED THAT THERE WAS A LEAK FROM Y SITE (WHITE). NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10395438 ↗MalfunctionJun 30, 2020Component Missing; Component Missing
IT WAS REPORTED THAT NO NEEDLE COVER. IT WAS STATED THE RN TAKE OTHER NEEDLE COVER TO IT. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10214480 ↗
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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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