Port Access Needle 0672010Recalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 00801741047923), received between Jun 28, 2019 and Sep 23, 2026 — classified as 7 injuries, 22 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (12 reports).

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.

Most reported problems

Recent adverse event reports

The 25 most recent of 29 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 23, 2026Activation Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50873055 ↗
• MalfunctionMay 6, 2026Detachment of Device or Device Component

  IT WAS REPORTED BY MEDSUN THE VASCULAR ACCESS NURSE WAS CONSULTED BY THE PATIENT'S PRIMARY RN TO ADDRESS THE ISSUE. PER THE PRIMARY RN, SHE AND ANOTHER NURSE WERE REPOSITIONING THE PATIENT, AND THE END OF THE CATHETER THAT CONNECTS TO THE NEEDLELESS VALVE DISCONNECTED FROM THE REST OF THE CATHETER. DEVICE WAS BEING USED FOR IV FLUIDS AND MEDICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25104806 ↗
• MalfunctionApr 28, 2026Activation Problem

  IT WAS REPORTED BY MEDSUN HUBER NEEDLE REMOVED FROM PATIENT DUE TO SAFETY NOT BEING ADEQUATELY ACTIVATED. PER STAFF REPORT THE SAFETY WAS VERY DIFFICULT TO ACTIVATE EVEN AFTER THE EVENT OCCURRED AND THE NEEDLE TIP REMAINED VISIBLE AND SLIGHTLY EXPOSED FOLLOWING ACTIVATION. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25016684 ↗
• MalfunctionApr 10, 2026

  HUBER NEEDLE REMOVED FROM PATIENT DUE TO SAFETY NOT BEING ADEQUATELY ACTIVATED. PER STAFF REPORT THE SAFETY WAS VERY DIFFICULT TO ACTIVATE EVEN AFTER THE EVENT OCCURRED AND THE NEEDLE TIP REMAINED VISIBLE AND SLIGHTLY EXPOSED FOLLOWING ACTIVATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24839023 ↗
• InjuryDec 10, 2025Activation Problem; Activation Problem

  IT WAS REPORTED I DE-ACCESSED THE PATIENT'S MEDIPORT AND THE HUBER NEEDLE JABBED ME IN THE FINGER AS I WAS PLACING THE NEEDLE INTO A SHARPS BOX. I HAD RETRACTED THE NEEDLE INTO THE SAFETY AS I PULLED IT OUT AND IT MADE A CLICK FEELING AS IF IT LOCKED INTO PLACE. I WAS SURPRISED WHEN I SUDDENLY FELT A NEEDLE STICK. I LOOKED AT THE HUBER AND THE NEEDLE WAS STICKING OUT ABOUT 1/3 OF A CM. FROM THE SHIELD. I PULLED BACK AND THE NEEDLE CLICKED BACK INTO THE SAFETY SHIELD BUT WHEN I GENTLY BUMPED THE HEAD OF THE NEEDLE, THE SHARP POINT POPPED BACK OUT AGAIN PART WAY. CLEARLY THE NEEDLE WAS NOT LOCKING INTO THE SAFETY SHIELD. TESTING WAS NEGATIVE FOR HIV, HEP C AND HEP B. NO PROPHYLAXIS REQUIRED.

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

  MAUDE report 23768114 ↗
• InjuryDec 10, 2025Activation Problem; Activation Problem

  IT WAS REPORTED I DE-ACCESSED THE PATIENT'S MEDIPORT AND THE HUBER NEEDLE JABBED ME IN THE FINGER AS I WAS PLACING THE NEEDLE INTO A SHARPS BOX. I HAD RETRACTED THE NEEDLE INTO THE SAFETY AS I PULLED IT OUT AND IT MADE A CLICK FEELING AS IF IT LOCKED INTO PLACE. I WAS SURPRISED WHEN I SUDDENLY FELT A NEEDLE STICK. I LOOKED AT THE HUBER AND THE NEEDLE WAS STICKING OUT ABOUT 1/3 OF A CM. FROM THE SHIELD. I PULLED BACK AND THE NEEDLE CLICKED BACK INTO THE SAFETY SHIELD BUT WHEN I GENTLY BUMPED THE HEAD OF THE NEEDLE, THE SHARP POINT POPPED BACK OUT AGAIN PART WAY. CLEARLY THE NEEDLE WAS NOT LOCKING INTO THE SAFETY SHIELD. TESTING WAS NEGATIVE FOR HIV, HEP C AND HEP B. NO PROPHYLAXIS REQUIRED.

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

  MAUDE report 23767967 ↗
• InjuryDec 10, 2025Activation Problem; Activation Problem

  IT WAS REPORTED I DE-ACCESSED THE PATIENT'S MEDIPORT AND THE HUBER NEEDLE JABBED ME IN THE FINGER AS I WAS PLACING THE NEEDLE INTO A SHARPS BOX. I HAD RETRACTED THE NEEDLE INTO THE SAFETY AS I PULLED IT OUT AND IT MADE A CLICK FEELING AS IF IT LOCKED INTO PLACE. I WAS SURPRISED WHEN I SUDDENLY FELT A NEEDLE STICK. I LOOKED AT THE HUBER AND THE NEEDLE WAS STICKING OUT ABOUT 1/3 OF A CM. FROM THE SHIELD. I PULLED BACK AND THE NEEDLE CLICKED BACK INTO THE SAFETY SHIELD BUT WHEN I GENTLY BUMPED THE HEAD OF THE NEEDLE, THE SHARP POINT POPPED BACK OUT AGAIN PART WAY. CLEARLY THE NEEDLE WAS NOT LOCKING INTO THE SAFETY SHIELD. TESTING WAS NEGATIVE FOR HIV, HEP C AND HEP B. NO PROPHYLAXIS REQUIRED.

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

  MAUDE report 23767850 ↗
• InjuryDec 10, 2025Activation Problem; Activation Problem

  IT WAS REPORTED I DE-ACCESSED THE PATIENT'S MEDIPORT AND THE HUBER NEEDLE JABBED ME IN THE FINGER AS I WAS PLACING THE NEEDLE INTO A SHARPS BOX. I HAD RETRACTED THE NEEDLE INTO THE SAFETY AS I PULLED IT OUT AND IT MADE A CLICK FEELING AS IF IT LOCKED INTO PLACE. I WAS SURPRISED WHEN I SUDDENLY FELT A NEEDLE STICK. I LOOKED AT THE HUBER AND THE NEEDLE WAS STICKING OUT ABOUT 1/3 OF A CM. FROM THE SHIELD. I PULLED BACK AND THE NEEDLE CLICKED BACK INTO THE SAFETY SHIELD BUT WHEN I GENTLY BUMPED THE HEAD OF THE NEEDLE, THE SHARP POINT POPPED BACK OUT AGAIN PART WAY. CLEARLY THE NEEDLE WAS NOT LOCKING INTO THE SAFETY SHIELD. TESTING WAS NEGATIVE FOR HIV, HEP C AND HEP B. NO PROPHYLAXIS REQUIRED.

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

  MAUDE report 23767849 ↗
• InjuryDec 10, 2025Activation Problem; Activation Problem

  IT WAS REPORTED I DE-ACCESSED THE PATIENT'S MEDIPORT AND THE HUBER NEEDLE JABBED ME IN THE FINGER AS I WAS PLACING THE NEEDLE INTO A SHARPS BOX. I HAD RETRACTED THE NEEDLE INTO THE SAFETY AS I PULLED IT OUT AND IT MADE A CLICK FEELING AS IF IT LOCKED INTO PLACE. I WAS SURPRISED WHEN I SUDDENLY FELT A NEEDLE STICK. I LOOKED AT THE HUBER AND THE NEEDLE WAS STICKING OUT ABOUT 1/3 OF A CM. FROM THE SHIELD. I PULLED BACK AND THE NEEDLE CLICKED BACK INTO THE SAFETY SHIELD BUT WHEN I GENTLY BUMPED THE HEAD OF THE NEEDLE, THE SHARP POINT POPPED BACK OUT AGAIN PART WAY. CLEARLY THE NEEDLE WAS NOT LOCKING INTO THE SAFETY SHIELD. TESTING WAS NEGATIVE FOR HIV, HEP C AND HEP B. NO PROPHYLAXIS REQUIRED. EMPLOYEE CHOSE TO HAVE BASELINE LAB WORK COMPLETED.

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

  MAUDE report 23767841 ↗
• InjuryDec 10, 2025Activation Problem; Activation Problem

  IT WAS REPORTED I DE-ACCESSED THE PATIENT'S MEDIPORT AND THE HUBER NEEDLE JABBED ME IN THE FINGER AS I WAS PLACING THE NEEDLE INTO A SHARPS BOX. I HAD RETRACTED THE NEEDLE INTO THE SAFETY AS I PULLED IT OUT AND IT MADE A CLICK FEELING AS IF IT LOCKED INTO PLACE. I WAS SURPRISED WHEN I SUDDENLY FELT A NEEDLE STICK. I LOOKED AT THE HUBER AND THE NEEDLE WAS STICKING OUT ABOUT 1/3 OF A CM. FROM THE SHIELD. I PULLED BACK AND THE NEEDLE CLICKED BACK INTO THE SAFETY SHIELD BUT WHEN I GENTLY BUMPED THE HEAD OF THE NEEDLE, THE SHARP POINT POPPED BACK OUT AGAIN PART WAY. CLEARLY THE NEEDLE WAS NOT LOCKING INTO THE SAFETY SHIELD. TESTING WAS NEGATIVE FOR HIV, HEP C AND HEP B. NO PROPHYLAXIS REQUIRED.

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

  MAUDE report 23767839 ↗
• MalfunctionMay 22, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT PORT NEEDLE HAS A Y-SITE WHERE BLOOD GETS TRAPPED. IT IS VERY DIFFICULT TO FLUSH AND CLEAR THE BLOOD FROM THIS AREA. THE MICROCLAVES ATTACHED TO THE Y-SITE FREQUENTLY ARE LOOSE, LEAK, OR POP OFF. THIS HAD LED TO ISSUES DURING BLOOD TRANSFUSION AND CHEMOTHERAPY LEAKS. THE DIFFICULTY CLEARING BLOOD DOES NOT SEEM TO BE MICROCLAVE RELATED. IT WAS REPORTED THIS OCCURRED WITH TEN DEVICES. THIS REPORT ADDRESSES ALL TEN DEVICES. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22070690 ↗
• MalfunctionOct 28, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY CUSTOMER THAT 1 INCH PORT NEEDLE Y-SITE LEAKING CHEMO ON A PATIENT. WE ARE UNABLE TO USE THE DISTAL PORT AND INSTEAD HAVE TO CLAMP IT OFF AND ONLY USE THE PROXIMAL PORT TO AVOID BACK FLUSHING OR SPILLS FROM THAT SITE.

  Patient problems: Chemical Exposure

  MAUDE report 20549381 ↗
• MalfunctionOct 25, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY CUSTOMER THAT 1 INCH Y-SITE PORT NEEDLE LEAKING ON BLOOD TRANSMISSION. WE ARE UNABLE TO USE THE DISTAL PORT AND INSTEAD HAVE TO CLAMP IT OFF AND ONLY USE THE PROXIMAL PORT TO AVOID BACK FLUSHING OR SPILLS FROM THAT SITE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20533474 ↗
• InjurySep 18, 2024Activation Problem; Activation Problem

  IT WAS REPORTED VIA MS&S "CUSTOMER STATES ONE OF HER NURSES HAD A NEEDLE STICK OCCUR WHILE USING THE POWERLOC SAFETY NEEDLE AND ASKING WHAT SAFETY MECHANISM IS FOR THIS DEVICE? IS IT RETRACTING, BLUNTING, SLIDING SHEATH OR HINGED CAP? MS&S EXPLAINED TO THE CUSTOMER, THIS IS A RETRACTING SAFETY NEEDLE. PLEASE SEE THE ATTACHED INSTRUCTIONS FOR USE. UNDER THE REMOVAL SECTION IT STATES "WHILE HOLDING THE NEEDLE BASE AGAINST THE SKIN, PULL TEXTURED HANDLE UP UNTIL YOU FEEL A STOP AND THE NEEDLE IS LOCKED IN THE SAFETY POSITION." NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Needle Stick/Puncture

  MAUDE report 20251296 ↗
• MalfunctionMay 16, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY THE CUSTOMER THAT AFTER INSERTION, VAT FLUSHED LINE AND SALINE SQUIRTED OUT AT THE RIGHT DEGREE BEND AT THE PATIENTS FACE. NO PATIENT HARM, PORT JUST NEEDED TO BE DE ACCESSED AND RE ACCESSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19333652 ↗
• MalfunctionMay 9, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT PORT NEEDLE IS LEAKING AND WAS TAKEN OUT OF THE PATIENT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19278796 ↗
• MalfunctionJun 1, 2023Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  IT WAS REPORTED THAT PORT A CATH TUBING BROKE AT THE SITE WHERE TUBING CONNECTS TO HUB. COMPLETELY BROKE APART. ADDITIONAL INFORMATION RECEIVED.: THE EVENT DID NOT OCCUR DURING A LIFE-THREATENING OR URGENT MEDICAL SITUATION. THE BREAK WAS DISCOVERED DURING ROUTINE INSPECTION. NORMAL SALINE WAS USED BUT NOTHING WAS INFUSING AT THE TIME OF EVENT. PATIENT HAD TO BE DEACCESSED AND REACCESSED. PORT ACCESS IS A VERY STRESSFUL PROCEDURE FOR THE PEDIATRIC POPULATION CAUSING UNNECESSARY DISTRESS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17038692 ↗
• MalfunctionMay 10, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY THE CUSTOMER "PATIENT WAS NOTED TO HAVE BLOOD BACKING UP AND OUT OF PORT TUBING. IT WAS FOUND THAT HIS PORT TUBING HAD BROKEN AT THE DISTAL END JUST ABOVE WHERE CLAVE CONNECTS. UNKNOWN HOW LONG TUBING HAD BEEN BROKEN, INCREASING PTS RISK FOR CENTRAL LINE INFECTION AND BLOOD LOSS. PATIENT REQUIRED RE-ACCESS, CAUSING HIM TO BE STUCK AGAIN." NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16903776 ↗
• MalfunctionApr 11, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT LINE BROKE DURING CHEMOTHERAPY INFUSION. (B)(6) 2023 ADDITIONAL INFORMATION EVENT DID NOT INVOLVE ANY URGENT/LIFE THREATENING MEDICATION SITUATION. PORT TUBING BROKEN AT THE DISTAL END JUST ABOVE CLAVE CONNECTION. BLOOD BACKED UP INTO TUBING AND ONTO BED. THIS CAUSED SIGNIFICANT DISTRESS FOR THIS CHILD AND THEIR PARENTS. ALSO DISTRESSED BY BEING DE-ACCESSED AND THEN RE-ACCESSED. NO MEDS INFUSING AT THE MOMENT.

  Patient problems: Emotional Changes

  MAUDE report 16714630 ↗
• MalfunctionMar 22, 2023Crack; Crack

  IT WAS REPORTED BY THE CUSTOMER THAT "POWERLOC NEEDLE CRACKING AT CONNECTION POINT". NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16589312 ↗
• MalfunctionMar 14, 2023Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  IT WAS REPORTED HUBER NEEDLE CRACKED. THERE WAS NO PATIENT HARM AND NO ADVERSE OUTCOME. IT WAS STATED NEEDLE WAS USED ON A PATIENT AND IT IS CONTAMINATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16541729 ↗
• MalfunctionApr 29, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY PATIENT "I HAVE A HOME HEALTH NURSE WHO COMES TO MY HOUSE TO ACCESS ME. ON WEDNESDAY, SHE USED A NEW NEEDLE & WHEN I HOOKED UP TO THE PUMP IS STARTED LEAKING SO I WENT TO GRAVITY FLOW & IT WAS STILL LEAKING. I GOT IN WITH A SURGEON YESTERDAY AS AN EMERGENCY & HE COULDN'T CHANGE IT BECAUSE HE DIDN'T HAVE ANY NEEDLES IN SUPPLY & I DIDN'T HAVE MINE WITH ME. SURGEON SAID IT WAS IN PLACE, FLUSHED IT WITH SALINE & GOT BLOOD RETURN. HE ASSUMED WHERE THE TUBING CONNECTING TO THE NEEDLE WASN'T ATTACHED CORRECTLY. ADDITIONAL INFORMATION RECEIVED 04/12/2022: IT WAS STATED THAT THE NEEDLE WAS REMOVED WEDNESDAY ABOUT 6 PM (B)(6) 2022.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14251159 ↗
• MalfunctionFeb 16, 2022Break; Break

  IT WAS REPORTED "PRODUCT FELL APART DURING USE." NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13546148 ↗
• MalfunctionMar 26, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED "LEAKING FROM "Y" SITE SHORT END BELOW CONNECTION."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11577163 ↗
• MalfunctionJan 20, 2021Leak/Splash

  IT WAS REPORTED THEY HAD A LEAKING POWER LOC. THEY DID NOT SAVE THE PRODUCT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 11203272 ↗