Port Access Needle LH-0035YNRecalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00801741066290), received between Jan 2, 2020 and Jan 9, 2025 — classified as 14 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (8 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-2669-2020 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 9, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE PORT NEEDLE HAD BEEN INSITU FOR ABOUT 3 DAYS WHEN THE NURSE NOTICED IT STARTED LEAKING WHEN THEY WERE FLUSHING THROUGH ONE SIDE OF THE Y SET. THE WAS NO INCREASE OF RESISTANCE DURING FLUSHING AND THE PORT IS NOT BLOCKED. THE PORT NEEDLE SET HAS ONE BONDED NEEDLELESS DEVICE AND ONE WHERE WE HAVE TO ATTACH A SINGLE NEEDLELESS DEVICE. IT WAS THE BONDED NEEDLELESS DEVICE THAT WAS LEAKING. NO HARM WAS CAUSED TO THE PATIENT, THE PORT NEEDLE WAS REMOVED EARLY DUE TO THE ISSUE AND A DIFFERENT NEEDLE INSERTED. NO OTHER INFORMATION PROVIDED, AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21115053 ↗
• MalfunctionDec 29, 2023Defective Component; Defective Component

  IT WAS REPORTED THAT WHEN BLOOD RETURN WAS ATTEMPTED TO BE CONFIRMED, AIR WAS ASPIRATED. THERE WAS NO REPORTED PATIENT INJURY. (B)(6) 2023 - A FUNCTIONAL TEST REVEALED THAT AIR COULD ENTER TWO INFUSION SETS THROUGH THE Y-SITE DURING ASPIRATION. THIS REPORT ADDRESSES THE SECOND DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18416957 ↗
• MalfunctionDec 28, 2023Defective Component; Defective Component

  IT WAS REPORTED THAT WHEN BLOOD RETURN WAS ATTEMPTED TO BE CONFIRMED, AIR WAS ASPIRATED. THERE WAS NO REPORTED PATIENT INJURY. (B)(6) 2023 - A FUNCTIONAL TEST REVEALED THAT AIR COULD ENTER TWO INFUSION SETS THROUGH THE Y-SITE DURING ASPIRATION. THIS REPORT ADDRESSES THE FIRST DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18414231 ↗
• MalfunctionSep 5, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT WHEN THE DEVICE WAS PRIMED PRIOR TO USE, AIR WAS ASPIRATED WHEN THE PLUNGER OF THE SYRINGE WAS PULLED. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17684615 ↗
• MalfunctionJun 10, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY THE CUSTOMER WHEN THE DEVICE WAS PRIMED WITH SALINE SOLUTION PRIOR TO USE, AIR WAS ASPIRATED AND AIR CONTAMINATION WAS FOUND. THERE WAS NO REPORTED PATIENT INVOLVEMENT.IT WAS REPORTED THIS OCCURRED WITH TWO DEVICES. THIS REPORT ADDRESSES THE SECOND DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17102123 ↗
• MalfunctionJun 10, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY THE CUSTOMER WHEN THE DEVICE WAS PRIMED WITH SALINE SOLUTION PRIOR TO USE, AIR WAS ASPIRATED AND AIR CONTAMINATION WAS FOUND. THERE WAS NO REPORTED PATIENT INVOLVEMENT. IT WAS REPORTED THIS OCCURRED WITH TWO DEVICES. THIS REPORT ADDRESSES THE FIRST DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17102121 ↗
• MalfunctionNov 29, 2022Failure to Infuse; Failure to Infuse

  IT WAS REPORTED THAT WHEN THE NEEDLE WAS CONNECTED TO THE SYRINGE AND ATTEMPTED TO BE PRIMED, AIR COULD NOT BE REPLACED AND AIR BUBBLES COULD NOT BE COME OUT. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15880336 ↗
• MalfunctionOct 18, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY THE CUSTOMER "ON 9/28 OUR TEAM REPORTED THAT A SAFESTEP HUBER NEEDLE WAS FOUND TO BE CRACKED AND LEAKING WHILE IN USE. THERE WAS NO HARM TO THE PATIENT. "

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15629265 ↗
• MalfunctionJul 8, 2021Break; Break

  IT WAS REPORTED "THE ISSUE WAS WITH THE PT.'S IVAD. THE IVAD WAS ACCESSED TO THE PT. AND WAS HEP LOCKED AND MOM NOTICED THAT THE CAP AND THE CAP CONNECTOR AT THE END OF THE LUMEN COMPLETELY CAME OFF ON IT OWN. THERE IS A CLEAN BREAK FROM THE FROM THE LUMEN AND CAP CONNECTOR."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12140096 ↗
• MalfunctionJan 8, 2021Obstruction of Flow; Positioning Problem

  IT WAS REPORTED THAT THE BASE OF THE SAFESTEP COULD NOT BE MOVED WHEN THE NURSE CHECKED BEFORE USE, THEN IT WAS LOCKED BY SPD. THERE WAS NO REPORTED PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement

  MAUDE report 11142777 ↗
• MalfunctionJul 15, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE LEAKAGE WAS FOUND AROUND THE BASE AFTER STAYED FLUSHING ALTHOUGH RESISTANCE WAS FELT, AFTER PRIMING WITH HEPARIN SALINE SOLUTION, PUNCTURING INTO THE PORT AND BLOOD RETURN CONFIRMED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10279950 ↗
• MalfunctionJun 19, 2020Defective Component; Defective Component

  IT WAS REPORTED THAT IT WAS FOUND THAT THE NEEDLE COVER WAS DETACHED FROM THE NEEDLE, SO THAT THE NEEDLE TIP WAS UNCOVERED UPON OPENING THE PACKAGE. THERE WAS NO REPORTED PATIENT CONTACT.

  Patient problems: No Patient Involvement

  MAUDE report 10176651 ↗
• MalfunctionJan 2, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT BY MEDICAL ORDER AND WITH STERILE TECHNIQUE, AN IMPLANTABLE CATHETER CONTROL LABORATORY IS TAKEN AND LEAKAGE IS OBSERVED BETWEEN THE CONNECTION OF NEEDLE EQUIPMENT. THERE IS NO INPUT DATA (IMPLANTABLE NEEDLE NUMBER 22, PLACED ON (B)(6) 2019."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9539753 ↗
• MalfunctionJan 2, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT SAFE STEP NEEDLE WITH LEAK.PARENTERAL NUTRITION WITHDRAWAL IS PERFORMED, CATHETER WASHING IS PERFORMED WITH PUSH STOP TECHNIQUE, DAMAGE IS OBSERVED (IN BLACK CLACE) OF THE 22X15 NEEDLE EXTENSION. 12/18/2019: THE CUSTOMER INFORMED THAT THE PRODUCT WAS USED IN THE PATIENT AS THE DEFECT WAS NOTICED DURING THE USE. THERE WAS NO DAMAGE TO THE PATIENT NOR THE HEALTH PROFESSIONAL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9539681 ↗