Port Access Needle LH-0030Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00801741066184), received between Jun 14, 2018 and Sep 10, 2026 — classified as 1 injury, 12 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (5 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.

Recalls naming this device

1. 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

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 10, 2026Activation Problem

  It was reported sheathing mechanism for withdrawing needle to cover sharp jamming halfway down needle. Additionally it took force to sheathe it closed once removed from patient. But no one was injured in the incident.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50717387 ↗
• MalfunctionMar 3, 2026Fluid/Blood Leak

  IT WAS REPORTED A NON-CORING NEEDLE WAS USED TO ACCESS A PATIENT'S PORT-A-CATH ON (B)(6) 2025. ON (B)(6) 2026, THE PATIENT REPORTED THAT HER PORT-A-CATH WAS LEAKING. UPON FURTHER ASSESSMENT, IT WAS NOTED THE EXTENSION TUBING WAS FOUND CRACKED WITH BLOOD BACKING ONTO INTO THE TUBING. IT IS UNCLEAR HOW THE EXTENSION TUBING ON THIS NON-CORING NEEDLE BROKE. THIS CAUSED THE PATIENT A DELAY TO THEIR TREATMENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24497056 ↗
• MalfunctionDec 30, 2025Activation Problem; Activation Problem

  IT WAS REPORTED THAT SAFESTEP IS DIFFICULT TO REMOVE; THE NEEDLE COMES OUT. NO FURTHER INFORMATION PROVIDED. IT WAS REPORTED THIS OCCURRED WITH 4 DEVICES. THIS REPORT ADDRESSES ALL 4 DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23931391 ↗
• MalfunctionDec 12, 2025Misassembled; Component Missing; Misassembled; Component Missing

  IT WAS REPORTED THAT WHEN OPENED THE HUBER NEEDLE, THE NEEDLE COVER WAS MISSING. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23790588 ↗
• InjuryJul 29, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED, PATIENT RECEIVING TREATMENT VIA 5FU INFUSION PUMPS EXPERIENCED LEAKAGE. CFU ACTIVATION DOES NOT ENGAGE. PATIENT IMPACT: PUNCTURE, SKIN IRRITATION. USE OF DMSO (PROTOCOL WHEN EXTRAVASATION 5 FU) AND COLD PACK APPLIED, REACTION TO DMSO AND USE OF CORTICOIDS, CAME TO HOSPITAL 3 TIMES FOR FOLLOW-UP.

  Patient problems: Extravasation; Skin Inflammation/ Irritation

  MAUDE report 22649104 ↗
• MalfunctionDec 13, 2024Material Twisted/Bent; Activation Problem; Material Twisted/Bent; Activation Problem

  IT WAS REPORTED THAT THE SAFETY MECHANISM DID NOT ACTIVATE WHEN REMOVING THE NEEDLE AFTER COMPLETION OF THE INFUSION. THERE WAS NO REPORTED PATIENT INJURY. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20926929 ↗
• MalfunctionOct 30, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY THE CUSTOMER PATIENT WAS ACCESSED FOR PORT FLUSH WITH ONE-INCH 22G PORT. PORT ACCESS SUCCESSFUL WITH GOOD BLOOD RETURN AND SITE FLUSHED WELL BUT AT THE END OF THE 10ML FLUSH IT WAS NOTED THAT SALINE WAS LEAKING OUT OF THE TOP OF THE PORT NEEDLE, AND IT APPEARED THE NEEDLE HAD A CRACK IN IT. ADDITIONAL INFORMATION RECEIVED 11/4/2024: IT WAS REPORTED BY THE CUSTOMER, THE EVENT HAPPENED AT THE END OF SEPTEMBER, THE PRODUCT WAS DISCARDED AND UNFORTUNATELY A PICTURE WAS NOT TAKEN. AS A RESULT, THE PORT HAD TO BE REACCESS WITH ANOTHER NEEDLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20569540 ↗
• MalfunctionJan 29, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING USE, BLOOD AND NORMAL SALINE EXPOSURE. NURSE SAW THE TUBE LEAKAGE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18602790 ↗
• MalfunctionOct 29, 2019Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE NEEDLE WAS FOUND BENT PRIOR TO USE. (B)(6) 2019 EVALUATION OF THE RETURNED SAMPLE REVEALED THE SAFETY MECHANISM COULD NOT BE ACTIVATED USING NORMAL MEANS AND FORCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9252571 ↗
• MalfunctionSep 14, 2019Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED VIA MEDWATCH, "PORT NEEDLE APPEARED TO HAVE DEBRIS IN TUBING."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9056657 ↗
• MalfunctionSep 13, 2019Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED VIA MEDWATCH, "PORT NEEDLE FILLED WITH AIR."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9039624 ↗
• MalfunctionSep 11, 2019Fluid/Blood Leak; Leak/Splash; Fluid/Blood Leak

  IT WAS REPORTED VIA MEDWATCH, "PATIENT ACCESSED WITH 22 GAUGE 1 INCH PORT, NOTED LEAKING FROM DEVICE." NO OTHER INFORMATION PROVIDED.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 8997640 ↗
• MalfunctionJun 14, 2018Air Leak

  IT WAS REPORTED NURSE ACCESSED ADULT PATIENT PORT AT HOME FOR ORDERED BLOOD DRAW. PORT ACCESSED WITHOUT PROBLEMS, INITIAL FLUSH, PATENCY CHECK O.K. AFTER DRAWING BLOOD, NURSE ADMINISTERED 2 (10 ML) NORMAL SALINE (PRE-FILLED) FLUSHES PER PROTOCOL. FIRST FLUSH WITHOUT INCIDENT. WHEN REACHING END OF SECOND NORMAL SALINE FLUSH (FLUSH CONTENT LEFT WAS APPROXIMATELY 1 ML), NURSE NOTICED A ¿SINGLE SMALL BUBBLE OF LIQUID¿ APPEARED AT THE AREA WHERE THE EXTENSION TUBING CONNECTS WITH THE INSERTION HANDLE. THE REMAINING SALINE (1 ML) WAS ADMINISTERED. NEXT, A 5 ML (100 U/ML) HEPARIN LOCK (PRE-FILLED SYRINGE) WAS ADMINISTERED (PRIOR TO DE-ACCESSING THE NEEDLE). WHEN INJECTING THE HEPARIN LOCK, UPON REACHING THE FINAL 1 ML MARK ON THE SYRINGE ¿ AGAIN, A ¿SINGLE SMALL BUBBLE OF LIQUID¿ APPEARED AT THE AREA WHERE THE EXTENSION TUBING MEETS THE NEEDLE INSERTION HANDLE. THE HEPARIN LOCK WAS COMPLETED BY THE NURSE (I.E. THE FINAL 1 ML OF HEPARIN WAS ADMINISTERED INTO THE PORT).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7604002 ↗