Port Access Needle LH-0038YNRecalls & reported problems
Bard Access Systems, Inc. · SafeStep 20G x 1.5 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
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00801741066351), received between Sep 28, 2023 and Sep 28, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (1 report).
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.
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
- Improper or Incorrect Procedure or Method1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 28, 2023Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method
IT WAS REPORTED VIA MS&S "NURSE WAS REQUESTING TROUBLESHOOTING ASSISTANCE FOR A PATIENT'S POWERPORT WITH PORT NEEDLE (REF LH-0028YN). STATES THE TECHNICIAN WAS NOT ABLE TO POWER INJECT THE CT CONTRAST AND KEPT GETTING A FAILURE ON THE POWER INJECTION MACHINE. ALSO, INQUIRING WHY THE MACHINE MAY HAVE FAILED AT COMPLETING A POWER INJECTION. ALSO, REQUESTING TO KNOW THE OTHER NON-POWER NEEDLES WE OFFER. NURSE NOT SURE IF THE PATIENT HAS A NON-POWER OR POWER RATED NEEDLE." MS&S RESPONSE "EXPLAINED LH-0038YN IS THE SAFESTEP NEEDLE. IT IS NOT POWER RATED AND HAS A MAX PSI OF 25. WE ALSO OFFER THE MINILOC NON-POWER NEEDLE. FOR POWER INJECTION TO BE SUCCESSFUL, THE PORT ACCESS NEEDLE AND THE PORT MUST BE POWER RATED. SOME POSSIBLE SOLUTIONS WOULD BE TO CONFIRM THE PATIENT HAS A POWER RATED PORT WITH A REFERENCE OR LOT NUMBER. ALSO, WE RECOMMEND WARMING THE CONTRAST TO BODY TEMPERATURE PRIOR TO INJECTION. THIS WILL HELP DECREASE THE VISCOSITY AND PSI DURING POWER INFECTION. WE ALSO RECOMMEND CHECKING FOR PATENCY PRIOR TO INJECTION OF CT CONTRAST. CUSTOMER STATES THEY DID ASPIRATE FOR BLOOD PRIOR TO INJECTION."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17839764 ↗
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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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