Port Access Needle LH-0032Recalls & reported problems

Summary

The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 00801741066221), received between Jun 1, 2018 and Aug 4, 2025 — classified as 3 injuries, 30 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (11 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, 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 33 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 4, 2025Fluid/Blood Leak; Failure to Infuse; Fluid/Blood Leak; Failure to Infuse

  IT WAS REPORTED THAT THERE WAS LEAKAGE AT THE DISC DURING BOLUS INJECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22701837 ↗
• MalfunctionAug 4, 2025Fluid/Blood Leak; Failure to Infuse; Fluid/Blood Leak; Failure to Infuse

  IT WAS REPORTED THAT THERE WAS LEAKAGE AT THE DISC DURING BOLUS INJECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22701835 ↗
• MalfunctionJun 17, 2025Material Twisted/Bent; Activation Problem; Material Twisted/Bent; Activation Problem

  IT WAS REPORTED THAT THE NEEDLE TIP CANNOT BE FULLY RETRACTED AFTER REMOVING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22247617 ↗
• MalfunctionJan 18, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT LEAKAGE AT THE NEEDLE INSERTION SITE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21186259 ↗
• MalfunctionNov 14, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY CUSTOMER THAT DURING THE CONTINUOUS ADMINISTRATION OF BLINATUMOMAB, THE TUBING IS CRACKING AT THE DISTAL SECTION OF PORT TUBING JUST ABOVE THE Q-SITE. ADDITIONAL INFORMATION RECEIVED 10/23/2024: IT WAS REPORTED BY THE CUSTOMER PATIENT WAS RECEIVING BLINATUMOMAB IN THE OUTPATIENT SETTING WHEN THE PORT LINE CRACKED AND REQUIRED READMISSION TO THE HOSPITAL OVERNIGHT TO BE RE-ACCESSED AND A NEW BAG OF CHEMOTHERAPY INITIATED. CRACK RESULTED IN TREATMENT DELAY, INABILITY FOR PATIENT TO RECEIVE TOTAL DRUG ORDERED AND UNNECESSARY PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20691648 ↗
• MalfunctionMar 12, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED, "NEEDLE SKEW." NO OTHER INFORMATION WAS PROVIDED. 02/16/2024: THE RETURNED DEVICE EXHIBITED A BENT NEEDLE NEAR THE NEEDLE BASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18888455 ↗
• InjuryMar 1, 2024Activation Problem; Activation Problem

  IT WAS REPORTED THAT WHEN REMOVING SAFE STEP NEEDLE, THE SAFETY MECHANISM OF THE NEEDLE WAS NOT ACTIVATED, CAUSING THE NEEDLE TO SEPARATE FROM THE BASE, RESULTING IN A NEEDLE STICK INCIDENT FOR NURSING STAFF. RESULTED IN BLOOD DRAW TO MONITOR BLOODSTREAM INFECTION. ADDITIONAL INFORMATION PROVIDED 2/22/2024: IT WAS REPORTED AFTER NEEDLESTICK, THE NURSE TOOK BLOOD TESTS, AND EVERYTHING WAS FINE.

  Patient problems: Needle Stick/Puncture

  MAUDE report 18815740 ↗
• MalfunctionSep 8, 2023Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT WHEN SALINE SOLUTION WAS INFUSED, A FOREIGN MATERIAL WAS FOUND AND THE DEVICE COULD NOT BE PRIMED. THERE WAS NO REPORTED PATIENT INVOLVEMENT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17708926 ↗
• MalfunctionJul 13, 2023Backflow; Fluid/Blood Leak; Backflow; Fluid/Blood Leak

  IT WAS REPORTED THAT BLOOD OOZES OUT OF THE NEEDLE AFTER THE INJECTION THE CUSTOMER KEEPS OUTLIER PRODUCT THEN FETCH IT BACK. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17316756 ↗
• MalfunctionMar 22, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED BY THE CUSTOMER THAT "PATIENT REPORTED HEARING A CLICKING NOISE AND NOTED IVAD TO BE RAISED FROM IT'S PREVIOUS POSITION IN CHEST. LET RN KNOW. WHEN RN ASSESSED, APPEARED RAISED. ITEM REMOVED BY RN AND NEW DEVICE INSERTED WITH NO ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16592359 ↗
• MalfunctionOct 12, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY THE CUSTOMER "THAT THE TUBING RIGHT ABOVE THE NEEDLE ON THE SAFESITE HUBER NEEDLE CRACKED"

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15587209 ↗
• MalfunctionAug 12, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED PATIENT'S MEDIAL SAFE STEP TUBING/NEEDLE CRACKED AND LEAKING. BLOOD FLOW BACK UP IN BOTH LUMENS, LATERAL LUMEN OF SAFE STEP NEEDLE ALSO PROBABLE PULLED BY PATIENT AND BLEEDING AT ACCESS SITE. BOTH LUMENS LIKELY OPEN FLOW DURING THIS TIME BEFORE DISCOVERED. PATIENT GRANDMOTHER CALLED OUT UPON REGISTERED NURSE ENTRY & ASSESSMENT OF PATIENT. THIS REGISTERED NURSE NOTED BLOOD FLOW IN BOTH MEDIAL & LATERAL LUMENS OF THE DOUBLE LUMEN PORT. MEDIAL TUBING FOUND TO BE CRACKED UPON FLUSH. BOTH NEEDLES DEACCESSED PER POLICY. BMT TEAM NOTIFIED. ADDITIONAL INFORMATION RECEIVED 08/02/2022: IS THIS A DUAL LUMEN PORT? O YES, IT WAS AS DUAL LUMEN PLACED ON (B)(6) 2021. WERE BOTH LUMENS ACCESSED? O YES, BOTH LUMENS WERE ACCESSED ON (B)(6) 2021 AT 1030AM. DID THIS HAPPEN MORE THAN ONE TIME TO THE PATIENT? O NO, THAT I HAVE DOCUMENTATION OF. ARE THERE ANY ISSUES WITH THE PORT? O NO DOCUMENTED ISSUES. BOTH PORT LUMENS FLUSHED EASILY AND HAD BRISK BLOOD RETURN AT THE TIME OF ACCESS ON (B)(6). NO CONCERNS WERE DOCUMENTED FROM 12/2 TO 12/7 WHEN LEAKING/CRACK WAS NOTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15221553 ↗
• MalfunctionAug 8, 2022Activation Problem; Activation Problem

  IT WAS REPORTED THAT THE NEEDLE CAN'T BE RETRACTED. IT WAS STATED CUSTOMER CHANGED NEW NEEDLE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15185688 ↗
• MalfunctionJan 11, 2022Activation Problem; Activation Problem

  IT WAS REPORTED "ONE OF OUR NURSES EXPERIENCED A NEEDLE STICK INJURY AS THE CACHE OF THE NEEDLE DID NOT WORK. SHE HEARD THE CLICK SOUND BUT THE NEEDLE WAS STILL EXPOSED. THE NEEDLE AS IT WAS DISPOSED DUE TO IT BEING USED TO INFUSE CYTOTOXIC DRUGS." WHAT IS THE VITAL STATUS OF NURSE EXPERIENCING STICK INJURY? ANY ADVERSE EVENT OBSERVED? NURSE IS WELL. WE HAVE DONE SOME BLOODS FOR HER, HIV AND HEPATITIS CHECK, ALL IS NORMAL. ANY MEDICAL TREATMENT PROVIDED DUET TO NEEDLE STICK INJURY? NO MEDICAL TREATMENT NEEDED AS NURSE IS WELL

  Patient problems: Needle Stick/Puncture

  MAUDE report 13232479 ↗
• MalfunctionAug 4, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AIR LEAKAGE WAS FOUND IN THE TUBE DURING INJECTION. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12277591 ↗
• 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 11473372 ↗
• InjurySep 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE USE OF SAFESTEP 20GA X 1 IN. NEEDLE CAUSED A PATIENT TO BE HOSPITALIZED WITH BACTEREMIA AND SUBSEQUENT PORT REPLACEMENT. MEDWATCH RCVD 09/15/2020: PATIENT REPORTED THAT HUBER POWERLOC NEEDLE LINE IS SPLITTING. SHE SWITCHED TO SAFESTEP, WHICH WAS ALSO SPLITTING. THEN A RECALL ON THESE PRODUCTS WAS RELEASED. THE PATIENT DEVELOPED SWELLING AND A LUMP AT HER PORT SITE. SHE THEN DEVELOPED FEVER AND WAS HOSPITALIZED. HER PORT IS BEING REMOVED AND A MIDLINE WILL IV WILL BE PLACED SO THAT SHE RECEIVE IV ANTIBIOTICS. MORE INFORMATION TO FOLLOW AFTER SHE IS RELEASED FROM THE HOSPITAL AND WE CAN GET A FULL TIME LINE OF EVENTS AND LOT NUMBERS. HUBER POWERLOC 22GX1 (LOT# ASCYF018, ASCYF019, ASCZF026, ASDRF047, ASDRF048, ASDRF049, ASDRF050) HUBER SAFESTEP 22X0.5 (LOT# ASCYF013, ASCYF014, ASCZF029, ASCVF035, ASCVF038, ASCVF042); HUBER SAFESTEP 22X1 (LOT# ASDNF034, ASDNF049, ASDNF055, ASDPF015, ASDPF017, ASDPF024, ASDPF025, ASDPF026, ASDQF017, ASDRF066, ASDRF066, ASDUF120, ASDVF004, ASDVF009, ASDVF013, ASDVF016, ASDVF025).

  Patient problems: Sepsis

  MAUDE report 10518492 ↗
• MalfunctionFeb 26, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED "¿WE HAVE A PATIENT HERE THIS AM THAT RECEIVED ONE OF THE HUBER NEEDLES THAT WE WERE TRIALING. IT WAS PLACED ON TUESDAY LAST WEEK. SHE STATES THAT ON FRIDAY, THE TUBING ON THE NEEDLE SPLIT NEAR THE ACCESS PORT. SHE HAD TO GO THE ED THERE TO HAVE THE PORT RE-ACCESSED SINCE SHE NEEDED HER MEDS. TO MAKE MATTERS WORSE, DUE TO THE RULES THERE, HER PHENERGAN HAD TO BE GIVEN IM INSTEAD OF IV. "

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9757079 ↗
• InjuryFeb 19, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA MS&S, "CALLER ASKING FOR THE MATERIAL CONTENTS OF THE SAFESTEP PORT ACCESS NEEDLE. SHE STATES SHE IS HAVING A REACTION TO THIS DEVICE PRODUCT CODE LH-0032. SHE STATES HER SKIN IS RED AND BLISTERING. SHE STATES SHE HAS USED THE DELTEC GRIPPER PLUS DEVICE WITH 3M SENSITIVE TAPE AND IV3000 WITHOUT ISSUE. SHE STATES HER INSURANCE CHANGED AND SENT THE SAFESTEP NEEDLE USED WITH THE SAME 3M SENSITIVE TAPE AND IV3000 BUT NOW HAVING ISSUES. THE DOCTOR INSTRUCTED HER TO CHANGE BACK TO THE DELTEC PRODUCT BUT THE INSURANCE COMPANY WILL NOT ALLOW IT. MS&S "EXPLAINED THAT THE SAFESTEP NEEDLE ITSELF IS STAINLESS STEEL. THE TUBING AND HOUSING (FLUID PATH) CONTAIN PVC RIGID AND FLEXIBLE, ABS, POLYCARBONATE, SILICONE, AND ACRYLIC ADHESIVE. "

  Patient problems: Erythema; Reaction

  MAUDE report 9727919 ↗
• MalfunctionJan 9, 2020Adverse Event Without Identified Device or Use Problem; Activation Problem; Adverse Event Without Identified Device or Use Problem; Activation Problem

  IT WAS REPORTED THAT RESISTANCE WAS EXPERIENCED WHEN NEEDLE REMOVAL HANDLED BY NURSE, THEN REMOVE THE NEEDLE BY HOLD THE SAFETY PLATE AND WHICH CAUSED THE NEEDLE STAB TO THE NURSE'S LEFT HAND. THE SAFETY MECHANISM DID NOT ACTIVATE. AFTER THE NEEDLE STAB ISSUE, THE SAFETY MECHANISM WAS ACTIVATED BY UNIT HEAD NURSE.

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

  MAUDE report 9572105 ↗
• MalfunctionDec 20, 2019Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE NEEDLE TIP WAS BENT. 12/12/2019 - THE RETURNED SAMPLE SHOWED THAT THE BEND IN THE NEEDLE PREVENTED THE SAFETY MECHANISM FROM ACTIVATING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9501314 ↗
• MalfunctionOct 16, 2019Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE NEEDLE HAD A CRACKED CONNECTOR WHICH LEAKED BLOOD. IT WAS STATED THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9199954 ↗
• MalfunctionMay 31, 2019Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT WHEN USER ATTEMPT TO USE, A GREEN FOREIGN MATERIAL WAS FOUND ON THE CONNECTOR. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8659109 ↗
• MalfunctionMay 16, 2019Therapeutic or Diagnostic Output Failure

  IT WAS REPORTED THAT THE HUBER'S NEEDLE (CANNULA FOR PUNCTURE RESERVOIR 0.90X25MM 20G) AFTER USE, THE SAFETY DEVICE DID NOT ALLOW TO BE TRIGGERED. NO OTHER INFORMATION PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8615650 ↗
• MalfunctionApr 19, 2019Leak/Splash

  IT WAS REPORTED THAT THE PATENT WENT HOME WITH THE SAFESTEP NEEDLE WAS IN FOR SEVEN DAYS. IT IS FACILITY POLICY TO CHANGE IN SEVEN DAYS. DURING THE FLUSHING OF THE NEEDLE, THE NURSE NOTICED THE LEAK BETWEEN THE TUBING AND THE NEEDLE CONNECTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8533665 ↗