Port Access Needle LH-0033Recalls & reported problems

Summary

The FDA's MAUDE database contains 49 adverse event reports that list this exact device (DI 00801741066245), received between Aug 10, 2018 and Mar 31, 2025 — classified as 49 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (37 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 25 most recent of 49 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 31, 2025Contamination /Decontamination Problem; Material Deformation; Contamination /Decontamination Problem; Material Deformation

  CUSTOMER RETURNED SAMPLE WITH 3/4 HUBER NEEDLE CONTAINING LOOSE PLASTIC. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 21734778 ↗
• MalfunctionAug 22, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED EXTENSION BREAKS DURING USAGE CAUSING LEAKING OF CHEMOTHERAPY AND BIOLOGICAL FLUIDS. OCCURRED DURING USE. NURSES HAVE FOUND SEVERAL PORT NEEDLE EXTENSIONS BROKEN DURING INFUSION IN PEDIATRIC PATIENTS OF AROUND 4-5 YEARS OLD. THIS CAUSES LEAKAGE OF CHEMOTHERAPY AND BIOLOGICAL FLUIDS. IT HAS BEEN NECESSARY TO REMOVE THE NEEDLE AND PRICK THE RESERVOIR WITH A NEW ONE TO CONTINUE WITH THE TREATMENT. EXPOSURE TO BLOOD AND CYTOTOXICS. UNKNOWN IF OTHER MEASURES WERE TAKEN. THE HEALTH PERSONNEL WAS EXPOSED TO BLOOD OR BODILY FLUIDS. IT WAS REPORTED THIS OCCURRED WITH FIVE DEVICES. THIS REPORT ADDRESSES THE SECOND DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20027775 ↗
• MalfunctionAug 21, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED EXTENSION BREAKS DURING USAGE CAUSING LEAKING OF CHEMOTHERAPY AND BIOLOGICAL FLUIDS. OCCURRED DURING USE. NURSES HAVE FOUND SEVERAL PORT NEEDLE EXTENSIONS BROKEN DURING INFUSION IN PEDIATRIC PATIENTS OF AROUND 4-5 YEARS OLD. THIS CAUSES LEAKAGE OF CHEMOTHERAPY AND BIOLOGICAL FLUIDS. IT HAS BEEN NECESSARY TO REMOVE THE NEEDLE AND PRICK THE RESERVOIR WITH A NEW ONE TO CONTINUE WITH THE TREATMENT. EXPOSURE TO BLOOD AND CYTOTOXICS. UNKNOWN IF OTHER MEASURES WERE TAKEN. THE HEALTH PERSONNEL WAS EXPOSED TO BLOOD OR BODILY FLUIDS. IT WAS REPORTED THIS OCCURRED WITH FIVE DEVICES. THIS REPORT ADDRESSES THE FIFTH DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20023251 ↗
• MalfunctionAug 21, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED EXTENSION BREAKS DURING USAGE CAUSING LEAKING OF CHEMOTHERAPY AND BIOLOGICAL FLUIDS. OCCURRED DURING USE. NURSES HAVE FOUND SEVERAL PORT NEEDLE EXTENSIONS BROKEN DURING INFUSION IN PEDIATRIC PATIENTS OF AROUND 4-5 YEARS OLD. THIS CAUSES LEAKAGE OF CHEMOTHERAPY AND BIOLOGICAL FLUIDS. IT HAS BEEN NECESSARY TO REMOVE THE NEEDLE AND PRICK THE RESERVOIR WITH A NEW ONE TO CONTINUE WITH THE TREATMENT. EXPOSURE TO BLOOD AND CYTOTOXICS. UNKNOWN IF OTHER MEASURES WERE TAKEN. THE HEALTH PERSONNEL WAS EXPOSED TO BLOOD OR BODILY FLUIDS. IT WAS REPORTED THIS OCCURRED WITH FIVE DEVICES. THIS REPORT ADDRESSES THE THIRD DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20016687 ↗
• MalfunctionAug 20, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED EXTENSION BREAKS DURING USAGE CAUSING LEAKING OF CHEMOTHERAPY AND BIOLOGICAL FLUIDS. OCCURRED DURING USE. NURSES HAVE FOUND SEVERAL PORT NEEDLE EXTENSIONS BROKEN DURING INFUSION IN PEDIATRIC PATIENTS OF AROUND 4-5 YEARS OLD. THIS CAUSES LEAKAGE OF CHEMOTHERAPY AND BIOLOGICAL FLUIDS. IT HAS BEEN NECESSARY TO REMOVE THE NEEDLE AND PRICK THE RESERVOIR WITH A NEW ONE TO CONTINUE WITH THE TREATMENT. EXPOSURE TO BLOOD AND CYTOTOXICS. UNKNOWN IF OTHER MEASURES WERE TAKEN. THE HEALTH PERSONNEL WAS EXPOSED TO BLOOD OR BODILY FLUIDS. IT WAS REPORTED THIS OCCURRED WITH FIVE DEVICES. THIS REPORT ADDRESSES THE FOURTH DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20002936 ↗
• MalfunctionAug 20, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED EXTENSION BREAKS DURING USAGE CAUSING LEAKING OF CHEMOTHERAPY AND BIOLOGICAL FLUIDS. OCCURRED DURING USE. NURSES HAVE FOUND SEVERAL PORT NEEDLE EXTENSIONS BROKEN DURING INFUSION IN PEDIATRIC PATIENTS OF AROUND 4-5 YEARS OLD. THIS CAUSES LEAKAGE OF CHEMOTHERAPY AND BIOLOGICAL FLUIDS. IT HAS BEEN NECESSARY TO REMOVE THE NEEDLE AND PRICK THE RESERVOIR WITH A NEW ONE TO CONTINUE WITH THE TREATMENT. EXPOSURE TO BLOOD AND CYTOTOXICS. UNKNOWN IF OTHER MEASURES WERE TAKEN. THE HEALTH PERSONNEL WAS EXPOSED TO BLOOD OR BODILY FLUIDS. IT WAS REPORTED THIS OCCURRED WITH FIVE DEVICES. THIS REPORT ADDRESSES THE FIRST DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20001769 ↗
• MalfunctionAug 19, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT ON TWO OCCASIONS THE TUBES OF THE SAFESTEP NEEDLES HAVE SPLIT AT VARIOUS POINTS ON THE DEVICE. NO OTHER INFORMATION WAS PROVIDED. THIS REPORT ADDRESSES THE SECOND OCCASION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12343089 ↗
• MalfunctionAug 19, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT ON TWO OCCASIONS THE TUBES OF THE SAFESTEP NEEDLES HAVE SPLIT AT VARIOUS POINTS ON THE DEVICE. NO OTHER INFORMATION WAS PROVIDED. THIS REPORT ADDRESSES THE FIRST OCCASION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12343072 ↗
• MalfunctionJul 9, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE NEEDLE REMAINING IN PLACE FOR 7 DAYS OR MORE FOR VARIOUS REASONS (PARENERAL DIET, ANTIOBIO THERAPY IN PATIENTS WITH SEPSIS, WITH ANALGESICS FOR END OF LIFE), WE OBSERVED THAT SOME NEEDLES DID NOT REMAIN IN PLACE DESPITE THE STERILE STRIPS THAT USED THEM. MAINTAIN. THE NEEDLE BECOMES MOBILE AND UNSTABLE OVER TIME AND COMES OUT OF THE IMPLANTABLE CHAMBER DEVICE, WHICH LEADS TO EXTRAVASATIONS AND EVEN THE NEEDLE THAT COMES OUT COMPLETELY! THESE EVENTS TOOK PLACE ON SEVERAL OCCASIONS CAUSING UNTIMELY OR PERIPHERAL TRANSPLANTING IN IMMUNOCOMPROMISED PATIENTS WHO WERE ALREADY FRAGILE AND GENERALLY NO LONGER HAD VENOUS CAPITAL. IT WAS REPORTED THE EVENT HAPPENED ON SEVERAL OCCASIONS, HOWEVER, THE NUMBER OF INCIDENTS WAS NOT PROVIDED.

  Patient problems: Infiltration into Tissue

  MAUDE report 12143939 ↗
• MalfunctionApr 8, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED "BROKEN PORT-A CATH ON FRIDAY. HE RECEIVES 5 DAYS OF ARSENIC AND HL'S FOR HOME. ON FRIDAY ( DAY 5) HE STARTED TO LEAK." ADDITIONAL INFORMATION RECEIVED (B)(6) 2021. WHAT TYPE OF CATHETER SECUREMENT WAS UTILIZED? "PAC 19 G 3/4 INC" WAS THERE ANY PATIENT HARM REPORTED? "UNKNOWN - ?? AMOUNT OF LOST MEDICATION". WHAT THEY¿RE BEING TREATED FOR: "CANCER". "OTHER RELEVANT HISTORY: 'THIS HAPPENED LAST CYCLE - LAST DAY OF ARSENIC."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11633699 ↗
• MalfunctionMar 19, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED "EXTENSION TUBING IS CRACKING, CAUSING LEAKING IN LESS THAN 48 HOURS OF INFUSION."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11532127 ↗
• MalfunctionMar 12, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED PATIENT WAS SENT HOME ON CHEMOTHERAPY VIA A INFUSION PUMP. WHEN THEY CAME BACK TO THE CLINIC 96 HOURS FOR A BAG CHANGE, LEAKING WAS NOTED WITH THE BD/BARD PORT ACCESS NEEDLE. ADDITIONAL INFORMATION PROVIDED 02/23/2021: ". THE BREAK OCCURRED WHERE THE TUBING IS ATTACHED TO THE ACTUAL ENTIRE PORT, NOT SOMETHING THE NURSES ARE PUTTING ON." PEDIATRIC ONCOLOGY PATIENT WERE RECEIVING A: 28 DAY INFUSION, PEDIATRIC ONCOLOGY PATIENT HAD BAG OF DRUG CHANGED EVERY 72-96 HOURS (WHERE LEAKING IS BEING REPORTED BY PARENT OR CLINICIAN), ADMINISTERED BLINATUMUMAB (BRAND BLINCYTO), PATIENT SENT HOME WITH THE INFUSION THROUGH A CADD (SMITH MEDICAL) HOME INFUSION PUMP, LEAKING WAS REPORTED WHERE THE TUBING MEETS THE HUB WHERE ABOVE A NEEDLELESS CONNECTOR/CSTD WOULD BE CONNECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11473148 ↗
• MalfunctionJan 15, 2021Crack; Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED SAFESTEP HUBER NEEDLE HAS CRACKED DURING HOSPITALIZATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11178465 ↗
• MalfunctionJan 11, 2021Crack; Leak/Splash

  IT WAS REPORTED THE PATIENT EXPERIENCED CRACKING IN THE TUBING THAT LED TO LEAKING BY THE LUER CONNECTION. IT WAS REPORTED THIS EVENT OCCURRED TWICE. THIS REPORT ADDRESSES THE SECOND EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11152254 ↗
• MalfunctionJan 11, 2021Fluid/Blood Leak; Defective Component; Fluid/Blood Leak

  IT WAS REPORTED IT WAS FOUND DURING CHEMOTHERAPY INFUSION THAT THE NEEDLE WAS DEFECTIVE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11152192 ↗
• MalfunctionJan 11, 2021Crack; Fluid/Blood Leak

  IT WAS REPORTED THE PATIENT EXPERIENCED CRACKING IN THE TUBING THAT LED TO LEAKING BY THE LUER CONNECTION. IT WAS REPORTED THIS EVENT OCCURRED TWICE. THIS REPORT ADDRESSES THE FIRST EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11151561 ↗
• MalfunctionJan 6, 2021Break; Disconnection

  IT WAS REPORTED I ENTERED PATIENTS ROOM TO PERFORM SAFETY CHECKS TO FIND THE PATIENTS CENTRAL LINE (MEDIPORT) TUBING HAD BECOME BROKEN AND DISCONNECTED. THE PORTION OF THE DISCONNECTION WAS ATTACHED TO THE NEEDLE/INSERTION. PATIENT'S MEDIPORT WAS DE-ACCESSED AND THEN RE-ACCESSED IN STERILE FASHION. ADDITIONAL INFORMATION RECEIVED 12/15/2020 WEIGHT:(B)(6). "WAS THERE PATIENT HARM REPORTED?: NON TO DATE BUT CONCERN FOR CLABSI AND ALSO THIS IS A SMALL CHILD THAT HAD TO BE POKED." "WHAT THEYRE BEING TREATED FOR: HEPATOBLASTOMA

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11124832 ↗
• MalfunctionNov 25, 2020Protective Measures Problem

  IT WAS REPORTED VIA MEDWATCH "WHEN REMOVING THE PORT NEEDLE, SAFETY DID NOT WORK. NEEDLE EXPOSED TO NURSE AND PATIENT, NO INJURY." OCCURRED WHEN DEACCESSING PORT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10901103 ↗
• MalfunctionOct 21, 2020Fail-Safe Did Not Operate

  IT WAS REPORTED VIA MEDWATCH "MEDICAL ONCOLOGY USED A SAFESTEP 19G X0.75 INCH HUBER NEEDLE TO ACCESS PATIENT. NO ISSUES ACCESSING OR OBTAINING BLOOD. UPON DEACCESSING PATIENT, THE SAFETY FEATURE DID NOT WORK. NEEDLE REMOVED FROM PORT SIDE BUT WAS NOT PROTECTED AS THE SAFETY PIECE COMPLETED CAME OFF. NO HARM OR NEEDLE STICK" ADD INFO RCVD 10/06/2020: PLACEMENT INFO: ACCESSED AND BLOOD DRAWN ON (B)(6) 2020

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10715149 ↗
• MalfunctionOct 21, 2020Retraction Problem

  IT WAS REPORTED VIA MEDWATCH "WHEN DEACCESSIONING A PORT-A-CATH, THE PORT NEEDLE DID NOT RETRACT INTO THE SAFETY. THE NEEDLE HAD TO BE PHYSICALLY PULLED OUT OF THE PORT AND THE SAFETY WAS NOT ABLE TO BE APPLIED." PLACEMENT INFO: PORT A CATH SINGLE LUMEN-RIGHT INTERNAL JUGULAR NO HARM TO PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10714389 ↗
• MalfunctionJul 10, 2020Activation Problem; Activation Problem

  IT WAS REPORTED THAT WHEN THE NEEDLE WAS REMOVED FROM THE IMPLANTABLE VENOUS DEVICE, THE NEEDLE DID NOT RETRACT. REMAINED STUCK ON THE DRESSING IS WHEN THE NURSE WANTED TO TAKE IT OFF THAT SHE PRICKED HERSELF.

  Patient problems: Exposure to Body Fluids; Needle Stick/Puncture

  MAUDE report 10258892 ↗
• MalfunctionApr 1, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE TUBING LEAKING AND THEN WHEN ASSESSED TUBING EXTENDING FROM HUBER NEEDLE NOTED TO BE CRACKED. NO OTHER INFORMATION WAS PROVIDED. TWO DEVICES WERE RETURNED FOR EVALUATION. THIS REPORT ADDRESSES THE SECOND DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9914228 ↗
• MalfunctionApr 1, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THE HUBER NEEDLE WAS NOTED TO BE CRACKED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9913823 ↗
• MalfunctionMar 24, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED TUBING LEAKING AND THEN WHEN ASSESSED TUBING EXTENDING FROM HUBER NEEDLE NOTED TO BE CRACKED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9876123 ↗
• MalfunctionMar 24, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED TUBING LEAKING AND THEN WHEN ASSESSED TUBING EXTENDING FROM HUBER NEEDLE NOTED TO BE CRACKED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9876100 ↗