Port Access Needle LH-0034Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00801741066269), received between Jun 12, 2019 and Aug 22, 2024 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (6 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 22, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY THE CUSTOMER FOR ABOUT 4-5 MONTHS, NURSES HAVE FOUND THE EXTENSION SET BREAKS DURING USE, CAUSING LEAKING OF CHEMOTHERAPY AND BIOLOGICAL FLUIDS DURING INFUSION IN PEDIATRIC PATIENTS AROUND 4-5 YEARS OLD. ADDITIONAL INFORMATION RECEIVED ON 7/25/2024: IT WAS REPORTED BY THE CUSTOMER IT WAS NECESSARY TO REMOVE THE NEEDLE AND REPLACE THE RESERVOIR WITH A NEW ONE TO CONTINUE TREATMENT, CAUSING EXPOSURE OF PATIENT AND HEALTHCARE PROFESSIONAL TO BLOOD AND CYTOTOXINS. IT WAS REPORTED THIS OCCURRED WITH FIVE DEVICES. THIS REPORT ADDRESSES THE FIRST DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20027733 ↗
• MalfunctionAug 22, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY THE CUSTOMER FOR ABOUT 4-5 MONTHS, NURSES HAVE FOUND THE EXTENSION SET BREAKS DURING USE, CAUSING LEAKING OF CHEMOTHERAPY AND BIOLOGICAL FLUIDS DURING INFUSION IN PEDIATRIC PATIENTS AROUND 4-5 YEARS OLD. ADDITIONAL INFORMATION RECEIVED (B)(6)2024: IT WAS REPORTED BY THE CUSTOMER IT WAS NECESSARY TO REMOVE THE NEEDLE AND REPLACE THE RESERVOIR WITH A NEW ONE TO CONTINUE TREATMENT, CAUSING EXPOSURE OF PATIENT AND HEALTHCARE PROFESSIONAL TO BLOOD AND CYTOTOXINS. IT WAS REPORTED THIS OCCURRED WITH FIVE DEVICES. THIS REPORT ADDRESSES THE FIFTH DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20024116 ↗
• MalfunctionAug 21, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY THE CUSTOMER FOR ABOUT 4-5 MONTHS, NURSES HAVE FOUND THE EXTENSION SET BREAKS DURING USE, CAUSING LEAKING OF CHEMOTHERAPY AND BIOLOGICAL FLUIDS DURING INFUSION IN PEDIATRIC PATIENTS AROUND 4-5 YEARS OLD. ADDITIONAL INFORMATION RECEIVED 7/25/2024: IT WAS REPORTED BY THE CUSTOMER IT WAS NECESSARY TO REMOVE THE NEEDLE AND REPLACE THE RESERVOIR WITH A NEW ONE TO CONTINUE TREATMENT, CAUSING EXPOSURE OF PATIENT AND HEALTHCARE PROFESSIONAL TO BLOOD AND CYTOTOXINS. IT WAS REPORTED THIS OCCURRED WITH FIVE DEVICES. THIS REPORT ADDRESSES THE SECOND DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20009896 ↗
• MalfunctionAug 20, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY THE CUSTOMER FOR ABOUT 4-5 MONTHS, NURSES HAVE FOUND THE EXTENSION SET BREAKS DURING USE, CAUSING LEAKING OF CHEMOTHERAPY AND BIOLOGICAL FLUIDS DURING INFUSION IN PEDIATRIC PATIENTS AROUND 4-5 YEARS OLD. ADDITIONAL INFORMATION RECEIVED 7/25/2024: IT WAS REPORTED BY THE CUSTOMER IT WAS NECESSARY TO REMOVE THE NEEDLE AND REPLACE THE RESERVOIR WITH A NEW ONE TO CONTINUE TREATMENT, CAUSING EXPOSURE OF PATIENT AND HEALTHCARE PROFESSIONAL TO BLOOD AND CYTOTOXINS. IT WAS REPORTED THIS OCCURRED WITH FIVE DEVICES. THIS REPORT ADDRESSES THE FOURTH DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20007135 ↗
• MalfunctionAug 20, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY THE CUSTOMER FOR ABOUT 4-5 MONTHS, NURSES HAVE FOUND THE EXTENSION SET BREAKS DURING USE, CAUSING LEAKING OF CHEMOTHERAPY AND BIOLOGICAL FLUIDS DURING INFUSION IN PEDIATRIC PATIENTS AROUND 4-5 YEARS OLD. ADDITIONAL INFORMATION RECEIVED ON 7/25/2024: IT WAS REPORTED BY THE CUSTOMER IT WAS NECESSARY TO REMOVE THE NEEDLE AND REPLACE THE RESERVOIR WITH A NEW ONE TO CONTINUE TREATMENT, CAUSING EXPOSURE OF PATIENT AND HEALTHCARE PROFESSIONAL TO BLOOD AND CYTOTOXINS. IT WAS REPORTED THIS OCCURRED WITH FIVE DEVICES. THIS REPORT ADDRESSES THE THIRD DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20006638 ↗
• MalfunctionJun 12, 2019Break; Fluid/Blood Leak

  IT WAS REPORTED THAT THE HUBER NEEDLE WAS LEAKING DUE TO BREAK IN TUBING. IT WAS STATED THE BREAK DID NOT OCCUR UNTIL 2-3 DAYS AFTER INSERTION. NO PATIENT HARM REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8692459 ↗