Port Access Needle LH-0038Recalls & reported problems
Bard Access Systems, Inc. · SafeStep 20G x 1.5 inch · Class 2
All models of Port Access Needle (122)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00801741066344), received between Mar 30, 2023 and Jan 7, 2026 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (2 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-2671-2020 · Root cause: Process control · Recall details · FDA record ↗
Most reported problems
Device problems
- Fluid/Blood Leak2
- Activation Problem1
- Material Twisted/Bent1
- Misassembled1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 7, 2026Fluid/Blood Leak
IT WAS REPORTED WHEN THE PRODUCT PASSED THROUGH THE TUBING, THE TUBING WAS FOUND TO BE PUNCTURED. SOME OF THE PRODUCT LEAKED OUT. THERE WAS NO SERIOUS HARM TO THE PATIENT AS ANOTHER EQUIVALENT DEVICE WAS USED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23995652 ↗MalfunctionAug 15, 2024Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED BY CUSTOMER THAT PATIENT RECEIVING BLINA CAME INTO THE ED WITH BLINA STOPPED DUE TO TUBING OF PORT NEEDLE WHERE THE END CONNECTION PIECE IS BROKEN, PORT DE-ACCESSED AND RE-ACCESSED, AND BLINA REORDERED AND RESTARTED. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19995348 ↗MalfunctionMar 12, 2024Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED, "NEEDLE SKEW." NO OTHER INFORMATION WAS PROVIDED. 02/16/2024. THE RETURNED DEVICE EXHIBITED A BEND IN THE NEEDLE NEAR THE NEEDLE BASE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18888233 ↗MalfunctionMar 30, 2023Misassembled; Activation Problem; Misassembled; Activation Problem
CUSTOMER REPORTED THAT THE SAFETY SHEATH IS NOT PROJECTING FAR ENOUGH OVER THE NEEDLE BEVEL. CUSTOMER IS CONCERNED ABOUT SAFETY RISK TO ALL THOSE THAT HANDLE AND AN INFECTION RISK AS THE PACKAGING COULD BE PUNCTURED WITHOUT THE RN KNOWING THE STERILITY IS COMPROMISED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16644427 ↗
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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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