Port Access Needle LH-0033YNRecalls & reported problems

Summary

The FDA's MAUDE database contains 96 adverse event reports that list this exact device (DI 00801741066252), received between Aug 27, 2018 and Aug 25, 2026 — classified as 3 injuries, 93 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (52 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 16, 2026.

Recalls naming this device

1. Jun 19, 2020Terminated

   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 25 most recent of 96 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 25, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50434984 ↗
• MalfunctionFeb 25, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT, DURING THE PROCEDURE OF WASHING THE DEVICE FROM THE MAIN LINE (AFTER PERFORMING BLOOD SAMPLING), NOTE OF BLOOD SPLASH FROM THE 2ND LINE (VALVE NOT USED). NO FURTHER DETAIL WERE PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 24442662 ↗
• MalfunctionFeb 3, 2026Product Quality Problem; Material Twisted/Bent

  IT WAS REPORTED 19 G NEEDLE (0.75 IN) WAS INSERTED FOR TRANSFUSION OF PRBC. BRISK BLOOD RETURNED NOTED AND PATIENT DENIED NO DISCOMFORT. PATIENT TOLERATED TRANSFUSION WELL. WRITER WAS UNABLE TO RETRACT PORT-A-CATH NEEDLE AT THE END OF TRANSFUSION. FLUSHED WELL WITH NO CONCERNS. NO SUCCESS AFTER CHANGING POSITION. PORT-A-CATH NEEDLE REMOVED AS IS AFTER DIFFERENT ATTEMPTS FROM 4 DIFFERENT NURSES. PATIENT DENIED DISCOMFORT. PROLONGED PATIENT CARE, BUT NO SERIOUS HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24251879 ↗
• InjuryJan 6, 2026Fluid/Blood Leak

  IT WAS REPORTED A DROP OF CHEMOTHERAPY PASSED THROUGH THIS VALVE AND A PATIENT SUFFERED A MINOR BURN. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Caustic/Chemical Burns

  MAUDE report 23983307 ↗
• InjuryDec 29, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE PROBLEM IS THIS: WHEN WE INJECT, A SMALL DROP LEAKS THROUGH THE ANTI-REFLUX VALVE, WHICH SHOULDN'T HAPPEN. THE PROBLEM IS SUCH THAT A DROP OF CHEMOTHERAPY PASSED THROUGH THIS VALVE AND A PATIENT SUFFERED A MINOR BURN BECAUSE WE ONLY REALIZED THIS AT THE END OF THE TREATMENT. IT WAS REPORTED THIS OCCURRED WITH 2 DEVICES. THIS REPORT ADDRESSES BOTH DEVICES.

  Patient problems: Caustic/Chemical Burns

  MAUDE report 23908951 ↗
• MalfunctionNov 26, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED FLUSHING THROUGH THE PORT NEEDLE WHEN A DROP COMES OUT OF THE BLUE SCREW CONNECTOR/ONE-WAY VALVE ON THE TUBING. IT WAS ONLY NACL THIS TIME, NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23655777 ↗
• MalfunctionSep 16, 2025Contamination /Decontamination Problem; Material Deformation; Contamination /Decontamination Problem; Material Deformation

  IT WAS REPORTED THAT A SMALL FRAGMENT OF LOOSE WHITE PLASTIC WAS FOUND ON CLEAR BLUE LUER END OF SAFESTEP HUBER NEEDLE SET BEFORE APPLYING NEEDLELESS CONNECTOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23066570 ↗
• MalfunctionSep 16, 2025Contamination /Decontamination Problem; Material Deformation; Contamination /Decontamination Problem; Material Deformation

  IT WAS REPORTED WHILE GETTING PREPPED TO ACCESS A PORT-A-CATH WHEN CONNECTING CAP TO PORT NEEDLE NOTED EXTRA PIECE OF PLASTIC WITHIN CONNECTOR HUB. APPEARS A SMALL WHITE PIECE OF PLASTIC WITHIN THE HUB. DIFFERENT PORT NEEDLE RETRIEVED AND USED FOR ACCESS. DEVICE WAS CLEAN OR NOT USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23064465 ↗
• MalfunctionSep 3, 2025Activation Problem; Activation Problem

  IT WAS REPORTED BY CUSTOMER THAT THE PORT ACCESS DEVICE DID NOT FULLY RETRACT NEEDLE AFTER BEING DE-ACCESSED BY WRITER, NEEDLE IS STILL FULLY EXPOSED. PRIOR TO DE-ACCESSING, PORT WAS FLUSHING WELL AND WAS GIVING GOOD BLOOD RETURN. NO HARM TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22956043 ↗
• MalfunctionAug 27, 2025Contamination /Decontamination Problem; Material Deformation; Contamination /Decontamination Problem; Material Deformation

  IT WAS REPORTED THAT A PORT NEEDLE ASSESSED AND SHARD OF PLASTIC PRESENT INSIDE THE HUB WHERE WE WOULD ATTACH IT TO THE CONNECTOR TO PRIME WITH SALINE. PORT NEEDLE SET ASIDE AND ANOTHER USED FOR TODAY'S TREATMENT. THE INCIDENT OCCURRED PRIOR TO USE AND THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22907189 ↗
• MalfunctionAug 25, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED, PATIENT CAME TO TREATMENT AREA WITH A CHEMOTHERAPY BOTTLE HOOKED UP TO THE PORT. PATIENT NOTICED A BUBBLE IN THE NIGHT IN THE AREA OF THE PORT THAT HAS THE NEEDLELESS INJECTION Y SITE. PATIENT LOOKED AT THE PORT AGAIN THE NEXT MORNING AND THE BUBBLE WAS BIGGER. THE PORT IS A CLOSED SYSTEM SO PATIENT WAS VERY CONCERNED AS TO WHY THERE WAS A BUBBLE GROWING IN THE CHAMBER. PATIENT ARRIVED TO SYSTEMIC THERAPY AND DEMANDED TO GET THE BOTTLE DISCONNECTED EVEN THOUGH IT WAS STILL >60% FULL. RN CAREFULLY ASPIRATED FROM THE NEEDLELESS INJECTION Y SITE TO REMOVE THE BUBBLE AND BLOOD RETURN WAS NOTED. PORT WAS DISCONNECTED. IMPACT OF INCIDENT: DELAY TO TREATMENT/THERAPY. PATIENT DID NOT GET TO FINISH HIS FULL DOSE OF CHEMOTHERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22884946 ↗
• MalfunctionAug 20, 2025Contamination /Decontamination Problem; Material Deformation; Contamination /Decontamination Problem; Material Deformation

  IT WAS REPORTED BY THE CUSTOMER THAT SMALL WHITE PLASTIC PIECE IN THE HUB OF CONNECTOR OF PORT-A-CATH NEEDLE. NEW NEEDLE WAS RETRIEVED AND USED. DETECTED PRIOR TO USE, NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22851740 ↗
• MalfunctionAug 19, 2025Contamination /Decontamination Problem; Material Deformation; Contamination /Decontamination Problem; Material Deformation

  IT WAS REPORTED, SMALL PIECE OF PLASTIC IN HUB OF CONNECTOR OF THE PORT-A-CATH NEEDLE. NO EFFECT - DID NOT REACH PATIENT/PERSON; DETECTED BEFORE USE OR DOES NOT TOUCH PATIENT DURING USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22846516 ↗
• MalfunctionJul 30, 2025Contamination /Decontamination Problem; Material Deformation; Contamination /Decontamination Problem; Material Deformation

  IT WAS REPORTED SMALL PIECE OF WHITE PLASTIC FOUND IN LUMEN OF PORT NEEDLE WHEN PREPPING FOR PORT ACCESS. ISSUE WAS DETECTED BEFORE USE AND DOES NOT TOUCH PATIENT DURING USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22666209 ↗
• MalfunctionJul 28, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED, WENT TO ACCESS PORT A CATH AND NOTED EXTRA SMALL PIECE OF WHITE PLASTIC IN LEUR LOCK HUB. NO EFFECT - DID NOT REACH PATIENT/PERSON -- DETECTED BEFORE USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22632523 ↗
• MalfunctionJul 28, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT WHILE PREPPING TO ACCESS PORT-A-CATH AND NOTED SMALL EXTRA PIECE OF WHITE PLASTIC IN CANULA HUB OF PORT NEEDLE. USER CALLED FOR ANOTHER PORT NEEDLE AND ENSURED IT DID NOT HAVE THE PIECE. NO EFFECT: DID NOT REACH PATIENT/PERSON: DETECTED BEFORE USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22630411 ↗
• MalfunctionJul 1, 2025Contamination /Decontamination Problem; Material Deformation; Contamination /Decontamination Problem; Material Deformation

  IT WAS REPORTED, FOREIGN MATERIAL PRESENT IN DEVICE (PIECE OF DUST CAP IN LUER HUB OF SAFE STEP).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22378657 ↗
• MalfunctionJul 1, 2025Contamination /Decontamination Problem; Material Deformation; Contamination /Decontamination Problem; Material Deformation

  IT WAS REPORTED THAT WHEN CONNECTING A NEEDLESS CONNECTOR TO THE END OF HUBER NEEDLE TUBING THEY LOOKED INTO THE BLUE CONNECTOR PIECE AND NOTED A THIN WHITE PIECE OF PLASTIC.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22378345 ↗
• MalfunctionJul 1, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT FOREIGN MATERIAL (FM) WAS FOUND IN THE TUBING. NO PATIENT HARM, FM DETECTED BEFORE IT REACHED THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22374177 ↗
• MalfunctionJul 1, 2025Contamination /Decontamination Problem; Material Deformation; Contamination /Decontamination Problem; Material Deformation

  IT WAS REPORTED, PREPPING TO ACCESS PATIENTS PORT WHEN NOTED A SMALL PIECE OF WHITE PLASTIC IN HUB OF CONNECTOR OF PORT-A-CATH NEEDLE. NEW NEEDLE WAS RETRIEVED AND USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22374108 ↗
• MalfunctionJun 26, 2025Contamination /Decontamination Problem; Material Deformation; Contamination /Decontamination Problem; Material Deformation

  IT WAS REPORTED PATIENT WAS HERE FOR AN INFUSION. CLINICIAN WAS ACCESSING THE PORT. WHILE ACCESSING THE NON-CORING NEEDLE, NOTICED THERE WAS A LOOSE WHITE STRAND INSIDE CONNECTOR, GRABBED A NEW NON-CORING NEEDLE AND SAME THING HAPPENED. 3RD NON-CORING NEEDLE WAS FINE AND WAS ABLE TO ACCESS PATIENT PORT. THIS REPORT ADDRESSES THE SECOND NEEDLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22338296 ↗
• MalfunctionJun 26, 2025Contamination /Decontamination Problem; Material Deformation; Contamination /Decontamination Problem; Material Deformation

  IT WAS REPORTED PATIENT WAS HERE FOR AN INFUSION. CLINICIAN WAS ACCESSING THE PORT. WHILE ACCESSING THE NON-CORING NEEDLE, NOTICED THERE WAS A LOOSE WHITE STRAND INSIDE CONNECTOR, GRABBED A NEW NON-CORING NEEDLE AND SAME THING HAPPENED. 3RD NON-CORING NEEDLE WAS FINE AND WAS ABLE TO ACCESS PATIENT PORT. THIS REPORT ADDRESSES THE FIRST NEEDLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22338250 ↗
• MalfunctionJun 25, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED BY THE CUSTOMER LOOSE PLASTIC PIECE IN END OF THE HUBER NEEDLE OBSERVED PRIOR TO USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22332154 ↗
• MalfunctionJun 24, 2025Contamination /Decontamination Problem; Material Deformation; Contamination /Decontamination Problem; Material Deformation

  IT WAS REPORTED BY THE CUSTOMER WRITER PREPPING TO ACCESS PATIENT'S PORT WHEN NOTED PORT NEEDLE HAS EXTRA PIECE OF WHITE PLASTIC WITHIN HUB. DETECTED BEFORE USE, DID NOT REACH OR TOUCH PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22323026 ↗
• MalfunctionJun 24, 2025Contamination /Decontamination Problem; Material Deformation; Contamination /Decontamination Problem; Material Deformation

  IT WAS REPORTED BY THE CUSTOMER "PATIENT WAS HERE FOR AN INFUSION. WRITER WAS GOING TO ACCESS PATIENT'S PORT. WHEN INSPECTING THE PORT, NOTICED THERE WAS A LOOSE WHITE STRAND INSIDE THE CONNECTOR FOR THE NON-CORING NEEDLE DEVICE. WRITER GRABBED ANOTHER NON-CORING NEEDLE AND SAME THING HAPPENED." THIS REPORT ADDRESSES THE FIRST NEEDLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22320057 ↗