Port Access Needle 0141975Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 00801741047435), received between May 9, 2018 and Apr 2, 2026 — classified as 2 injuries, 20 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (18 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-2670-2020 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• InjuryApr 2, 2026Activation Problem

  IT WAS REPORTED THAT POST PATIENT FINISHING CHEMOTHERAPY, WAS DEACCESSING PORT HOWEVER DIDN'T RETRACT FULLY RESULTING IN NEEDLE STICK INJURY TO RIGHT RING FINGER AT THE BASE AREA, THAT WENT THROUGH THE GLOVE WHILE DISCARDING IT IN THE PURPLE HAZARD SHARPS BIN THAT WAS BESIDE THE PATIENT. FULL PPE WAS ON DURING THIS TIME. NO PATIENT INJURY WAS REPORTED. STAFF MEMBER DID NOT REQUIRE ANY MEDICATIONS FOLLOWING THE INCIDENT. IT WAS REPORTED THIS OCCURRED WITH 2 DEVICES. THIS REPORT ADDRESSES BOTH DEVICES.

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

  MAUDE report 24770154 ↗
• MalfunctionSep 10, 2025Fluid/Blood Leak; Fluid/Blood Leak

  ADDITIONAL INFORMATION: AFTER THE PORT PUNCTURE, DURING THE BLOOD ASPIRATION, AIR WAS DRAWN IN, THE PATIENT HAD TO BE STUNG A 2ND TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23017565 ↗
• MalfunctionSep 4, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED PORT NEEDLE POWERLOC MAX LEAKING. AFTER THE PORT PUNCTURE, DURING THE BLOOD ASPIRATION, AIR WAS DRAWN IN. THE PATIENT HAD TO BE POKED A 2ND TIME, BUT FORTUNATELY FURTHER DAMAGE WAS AVOIDED BY THE ATTENTION OF THE COLLEAGUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22968528 ↗
• MalfunctionMar 25, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED FLUID LEAKAGE IN THE AREA OF THE PATIENT'S PORT. SKIN IRRITATION DUE TO LEAKING CYTOSTATICS. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 21691996 ↗
• MalfunctionMar 17, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED, FLUID (FLUOROURACIL) LEAKAGE IN THE AREA OF THE CONNECTION VALVES USED, SPINNING SPIRO, CHECK VALVE (=K ZERO ADAPTER) IN CONNECTION WITH THE ELASTOMERIC PUMP. THIS HAS AT LEAST THE FOLLOWING NEGATIVE EFFECTS: UNCLEAR AMOUNT OF ACTUALLY INFUSED CYTOSTATIC DRUGS. SKIN IRRITATION DUE TO LEAKING CYTOSTATIC DRUGS. STRESSFUL SITUATION FOR THE PATIENT (PSYCHOLOGICAL COMPONENT). ENDANGERING THIRD PARTIES THROUGH THE UNCONTROLLED RELEASE OF CYTOSTATIC DRUGS. PORT NEEDLE HAS BEEN REMOVED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 21626644 ↗
• InjuryJan 13, 2025Activation Problem; Activation Problem

  IT WAS REPORTED THAT WHILE REMOVING A PORT-A-CATH NEEDLE, THE NEEDLE WAS UNEXPECTEDLY EXPOSED AND PENETRATED THE STAFF MEMBER¿S LEFT PALM. IT APPEARS THAT THE SAFETY MECHANISM OF THE NEEDLE MALFUNCTIONED, LEAVING THE NEEDLE EXPOSED AND RESULTING IN THE INJURY. ADDITIONAL INFORMATION RECEIVED ON 19-DEC-2024: THE DATE OF THE INCIDENT WAS DECEMBER 3RD, IT WAS A BLOOD EXPOSURE INCIDENT AS THE NEEDLE WAS REMOVED POST-TREATMENT. WE FOLLOWED OUR BLOOD AND BODY FLUID EXPOSURE INCIDENT PROCESS HERE. PATIENT WAS NOT IMPACTED BUT STAFF MEMBER WAS. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Needle Stick/Puncture

  MAUDE report 21138562 ↗
• MalfunctionSep 25, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY CUSTOMER THAT OUR INFUSION TEAM HAD A FEW LEAKS FROM THE POWER LOC. NO OTHER INFORMATION WAS PROVIDED. A SPECIFIC NUMBER OF AFFECTED DEVICES OR PATIENTS WAS NOT PROVIDED BY THE COMPLAINANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20305541 ↗
• MalfunctionAug 28, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT LEAKING TUBING, SPILT DOWN BOTTOM TOWARDS END WHERE NEEDLESS CONNECTOR ATTACHES. PATIENT HAD POC INSITU AND WAS ADMINISTERING MEDICATION AT HOME AS SHE ALWAYS HAS DONE, SHE FELT SOMETIME WET AND DISCOVERED THAT FLUID COMING OUT OF TUBING SO STOPPED USING POC, DE-ACCESSED AND THEN BROUGHT DEVICE IN TODAY AND WE SAW THE LEAKING FLUID. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20093088 ↗
• MalfunctionDec 22, 2023Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  NURSE REQUESTING THE PLASTIC MATERIALS USED FOR THE SAFESTEP AND MINILOC NEEDLES. STATES THEY HAVE NOTICED THAT THE PLASTIC TUBING IN THE SAFESTEP NEEDLE BREAKS DOWN WHEN INFUSING BLINATUMOMAB COMPARED TO THE MINILOC NEEDLE. SHE IS WONDERING IF THEY BOTH HAVE DIFFERENT PLASTIC MATERIALS. ALSO, INQUIRING IF THE MINILOC AND SAFESTEP NEEDLES ARE DEHP FREE. MS&S RESPONSE: INFORMED THE NEEDLE FOR THE MINILOC NEEDLE IS 304 STAINLESS STEEL, WITH ACRYLIC ADHESIVE AND SILICONE OIL. THE TUBING FOR THE MINILOC NEEDLE IS PVC (POLYVINYL CHLORIDE). OTHER MATERIALS INCLUDE POLYPROPYLENE, POLYETHERIMIDE, ABS (ACRYLONITRILE BUTADIENE STYRENE), RIGID PVC, AND LDPE (LOW-DENSITY POLYETHYLENE). THE FLUID PATH MATERIALS ARE FLEXIBLE PVC, RIGID PVC, ABS, 304 STAINLESS STEEL, UV-CURING ACRYLIC ADHESIVE, AND SILICONE. THE NEEDLE FOR THE SAFESTEP IS 304 STAINLESS STEEL, WITCH ACRYLIC ADHESIVE AND SILICONE OIL. THE TUBING FOR THE SAFESTEP NEEDLE IS PVC (POLYVINYL CHLORIDE). OTHER MATERIALS INCLUDE ABS (ACRYLONITRILE BUTADIENE STYRENE), RIGID PVC, AND POLYCARBONATE. THE FLUID PATH MATERIALS ARE FLEXIBLE PVC, RIGID PVC, ABS, POLYCARBONATE, SILICONE, UV-CURE ACRYLIC ADHESIVE, AND 304 STAINLESS STEEL. BOTH THE M

  Patient problems: Chemical Exposure

  MAUDE report 18387839 ↗
• MalfunctionDec 21, 2023Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  NURSE REQUESTING THE PLASTIC MATERIALS USED FOR THE SAFESTEP AND MINILOC NEEDLES. STATES THEY HAVE NOTICED THAT THE PLASTIC TUBING IN THE SAFESTEP NEEDLE BREAKS DOWN WHEN INFUSING BLINATUMOMAB COMPARED TO THE MINILOC NEEDLE. SHE IS WONDERING IF THEY BOTH HAVE DIFFERENT PLASTIC MATERIALS. ALSO, INQUIRING IF THE MINILOC AND SAFESTEP NEEDLES ARE DEHP FREE. MS&S RESPONSE: INFORMED THE NEEDLE FOR THE MINILOC NEEDLE IS 304 STAINLESS STEEL, WITH ACRYLIC ADHESIVE AND SILICONE OIL. THE TUBING FOR THE MINILOC NEEDLE IS PVC (POLYVINYL CHLORIDE). OTHER MATERIALS INCLUDE POLYPROPYLENE, POLYETHERIMIDE, ABS (ACRYLONITRILE BUTADIENE STYRENE), RIGID PVC, AND LDPE (LOW-DENSITY POLYETHYLENE). THE FLUID PATH MATERIALS ARE FLEXIBLE PVC, RIGID PVC, ABS, 304 STAINLESS STEEL, UV-CURING ACRYLIC ADHESIVE, AND SILICONE. THE NEEDLE FOR THE SAFESTEP IS 304 STAINLESS STEEL, WITCH ACRYLIC ADHESIVE AND SILICONE OIL. THE TUBING FOR THE SAFESTEP NEEDLE IS PVC (POLYVINYL CHLORIDE). OTHER MATERIALS INCLUDE ABS (ACRYLONITRILE BUTADIENE STYRENE), RIGID PVC, AND POLYCARBONATE. THE FLUID PATH MATERIALS ARE FLEXIBLE PVC, RIGID PVC, ABS, POLYCARBONATE, SILICONE, UV-CURE ACRYLIC ADHESIVE, AND 304 STAINLESS STEEL. BOTH THE M

  Patient problems: Chemical Exposure

  MAUDE report 18374613 ↗
• MalfunctionDec 8, 2023Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  IT WAS REPORTED VIA MS&S "NURSE REQUESTING THE PLASTIC MATERIALS USED FOR THE SAFESTEP AND MINILOC NEEDLES. STATES THEY HAVE NOTICED THAT THE PLASTIC TUBING IN THE SAFESTEP NEEDLE BREAKS DOWN WHEN INFUSING BLINATUMOMAB COMPARED TO THE MINILOC NEEDLE. SHE IS WONDERING IF THEY BOTH HAVE DIFFERENT PLASTIC MATERIALS. ALSO, INQUIRING IF THE MINILOC AND SAFESTEP NEEDLES ARE DEHP FREE." MS&S RESPONSE: "INFORMED THE NEEDLE FOR THE MINILOC NEEDLE IS 304 STAINLESS STEEL, WITH ACRYLIC ADHESIVE AND SILICONE OIL. THE TUBING FOR THE MINILOC NEEDLE IS PVC (POLYVINYL CHLORIDE). OTHER MATERIALS INCLUDE POLYPROPYLENE, POLYETHERIMIDE, ABS (ACRYLONITRILE BUTADIENE STYRENE), RIGID PVC, AND LDPE (LOW-DENSITY POLYETHYLENE). THE FLUID PATH MATERIALS ARE FLEXIBLE PVC, RIGID PVC, ABS, 304 STAINLESS STEEL, UV-CURING ACRYLIC ADHESIVE, AND SILICONE. THE NEEDLE FOR THE SAFESTEP IS 304 STAINLESS STEEL, WITCH ACRYLIC ADHESIVE AND SILICONE OIL. THE TUBING FOR THE SAFESTEP NEEDLE IS PVC (POLYVINYL CHLORIDE). OTHER MATERIALS INCLUDE ABS (ACRYLONITRILE BUTADIENE STYRENE), RIGID PVC, AND POLYCARBONATE. THE FLUID PATH MATERIALS ARE FLEXIBLE PVC, RIGID PVC, ABS, POLYCARBONATE, SILICONE, UV-CURE ACRYLIC ADHESIVE, AND 304

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18293410 ↗
• MalfunctionJul 31, 2023Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  IT WAS REPORTED BY THE CUSTOMER THAT A LOUD "POP" WAS HEARD AND THEN THERE WAS BLOOD ALL OVER THE PATIENT'S DRESSING. THE PORT NEEDLE TUBING HAD DETACHED FROM THE HUB. THE PORT NEEDLE WAS NOT CONNECTED TO AN INFUSION WHEN THIS OCCURRED. BLOOD RAN BACK INTO THE TUBE AND SPILLED OUT. THE PORT HAD BEEN ACCESSED WITH THIS NEEDLE FOR A FEW DAYS WHEN THE EVENT OCCURRED. THIS WAS ON A PORT-A-CATH, SMALLEST NEEDLE SIZE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 17424429 ↗
• MalfunctionMay 13, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED "ATTENDING PEDS ON DAY UNIT FOR TREATMENT ACCOMPANIED BY MOTHER. IVAD HAD BEEN ACCESSED PREVIOUSLY ON FEBRUARY 17TH FOR ONGOING TREATMENT. THE NURSE CARING FOR THE PATIENT ASSESSED THE LINE PRIOR TO GIVING CHEMOTHERAPY BY CHECKING FOR BLOOD RETURN AND NOTED THAT ONLY AIR RETURNED IN THE SYRINGE, NO BLOOD RETURN OR FLUID RETURN; SUSPECTED INVISIBLE BREAK IN LINE. BREAK IN TUBING VERIFIED ONCE THE AFFECTED HUBER NEEDLE WAS REMOVED AND EXAMINED. THE BREAK WAS FOUND WHERE THE MICROBORE TUBING OF THE IVAD NEEDLE EXTENSION SET MEETS THE LIGHT BLUE LUER CONNECTION." IT WAS STATED THIS OCCURRED TWO TIMES. THIS REPORT ADDRESSES THE FIRST DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14398208 ↗
• MalfunctionMay 13, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED "ATTENDING PEDS ON DAY UNIT FOR TREATMENT ACCOMPANIED BY MOTHER. IVAD HAD BEEN ACCESSED PREVIOUSLY ON FEBRUARY 17TH FOR ONGOING TREATMENT. THE NURSE CARING FOR THE PATIENT ASSESSED THE LINE PRIOR TO GIVING CHEMOTHERAPY BY CHECKING FOR BLOOD RETURN AND NOTED THAT ONLY AIR RETURNED IN THE SYRINGE, NO BLOOD RETURN OR FLUID RETURN; SUSPECTED INVISIBLE BREAK IN LINE. BREAK IN TUBING VERIFIED ONCE THE AFFECTED HUBER NEEDLE WAS REMOVED AND EXAMINED. THE BREAK WAS FOUND WHERE THE MICROBORE TUBING OF THE IVAD NEEDLE EXTENSION SET MEETS THE LIGHT BLUE LUER CONNECTION." IT WAS STATED THIS OCCURRED TWO TIMES. THIS REPORT ADDRESSES THE SECOND DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14398191 ↗
• MalfunctionApr 15, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED "POWERLOC-CRACKING AND LEAKING OF POWERLOC MAX DURING INFUSION" IT WAS STATED 3 DEVICES LEAKED. THIS REPORT ADDRESSES THE THIRD DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14117789 ↗
• MalfunctionApr 15, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED "POWERLOC-CRACKING AND LEAKING OF POWERLOC MAX DURING INFUSION" IT WAS STATED 3 DEVICES LEAKED. THIS REPORT ADDRESSES THE SECOND DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14117787 ↗
• MalfunctionApr 15, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED "POWERLOC-CRACKING AND LEAKING OF POWERLOC MAX DURING INFUSION" IT WAS STATED 3 DEVICES LEAKED. THIS REPORT ADDRESSES THE FIRST DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14117785 ↗
• MalfunctionJun 30, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED CUSTOMER HAD 3 INCIDENTS OF NEEDLE BREAKAGE. IT WAS STATED THERE WAS NO INJURY BUT A RISK OF CLASBI INFECTION (WHICH HAS NOT OCCURRED AS OF YET). THIS REPORT ADDRESSES THE THIRD INCIDENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10212400 ↗
• MalfunctionJun 30, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED CUSTOMER HAD 3 INCIDENTS OF NEEDLE BREAKAGE. IT WAS STATED THERE WAS NO INJURY BUT A RISK OF CLASBI INFECTION (WHICH HAS NOT OCCURRED AS OF YET). THIS REPORT ADDRESSES THE SECOND INCIDENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10212391 ↗
• MalfunctionJun 30, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED CUSTOMER HAD 3 INCIDENTS OF NEEDLE BREAKAGE. IT WAS STATED THERE WAS NO INJURY BUT A RISK OF CLASBI INFECTION (WHICH HAS NOT OCCURRED AS OF YET).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10212384 ↗
• MalfunctionMay 9, 2018Leak/Splash

  IT WAS REPORTED THAT THERE WAS A LEAK WHERE THE TUBING CONNECTED INTO THE HARD PLASTIC AT THE TOP OF THE HUBER NEEDLE. NO PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7500817 ↗
• MalfunctionMay 9, 2018Connection Problem

  IT WAS REPORTED BY A HEALTH PROFESSIONAL THAT THE PATIENT WAS ACCESSED WITH A HUBER 0.75 INCH POWER PORT NEEDLE. HE STATED, "I TWISTED THE BLUE LEUR LOCK CONNECTOR ON THE END IT WOULD NOT TIGHTEN DOWN. I TRIED ANOTHER BLUE CONNECTOR AND IT WOULD STILL NOT TIGHTEN UP AND SEAL PROPERLY. I THEN TRIED THOSE BLUE CONNECTORS ON THE END OF A DIFFERENT HUBER NEEDLE AND IT TIGHTENED JUST FINE." NO PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7500812 ↗