Port Access Needle 0652034Recalls & reported problems

Summary

The FDA's MAUDE database contains 67 adverse event reports that list this exact device (DI 00801741047763), received between Aug 22, 2018 and Sep 30, 2026 — classified as 3 injuries, 64 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (33 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 67 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Activation Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50954904 ↗
• MalfunctionSep 30, 2026Activation Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50954899 ↗
• MalfunctionJun 23, 2026Component Missing

  IT WAS REPORTED NURSING DISCOVERED NEEDLE WITH NO PROTECTIVE PLASTIC COVER ON NEEDLE WITHIN PACKAGE WHEN OPENING. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25602657 ↗
• InjuryMar 31, 2026Activation Problem

  IT WAS REPORTED AFTER AN ASSOCIATE'S NEEDLE STICK, THE ASSOCIATE REPORTED SOME CONCERNS REGARDING THE DEVICE 20G HUBER NEEDLE IN THE PROCESS OF REMOVING FROM PORT-A-CATH. THE SAFETY FEATURE WAS PARTIALLY ACTIVATED, THE INJURY OCCURRED AFTER ACTIVATING THE SAFETY FEATURE. ASSOCIATE BELIEVES THAT ACTIVATING THE SAFETY FEATURE WAS MORE DIFFICULT THAN IT USUALLY IS. NEEDLE USUALLY SLIDES INTO THE CATHETER SLEEVE UPON REMOVING FROM PORT-A-CATH BUT IT DID NOT SLIDE ALL THE WAY LIKE IT WAS SUPPOSE TO. THE CLINICIAN SUSTAINED A NEEDLE STICK INJURY AFTER NEEDLE WAS REMOVED FROM IMPLANTED PORT. NO FURTHER INFORMATION WAS PROVIDED.

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

  MAUDE report 24749950 ↗
• MalfunctionAug 1, 2025Activation Problem; Activation Problem

  IT WAS REPORTED BY CUSTOMER THAT THE NEEDLES NOT ENGAGING THE SAFETY LOCK. IT WAS REPORTED THIS OCCURRED WITH FOUR DEVICES. THIS REPORT ADDRESSES ALL FOUR DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22690128 ↗
• MalfunctionAug 1, 2025Activation Problem; Activation Problem

  IT WAS REPORTED BY CUSTOMER THAT THE NEEDLES NOT ENGAGING THE SAFETY LOCK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22690116 ↗
• MalfunctionJul 16, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED "WE HAD A CONTRAST EXTRAVASATION WITH ONE NEEDLE THAT WAS NOTED TO BE BENT UPON REMOVAL FROM THE PORT." NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Extravasation

  MAUDE report 22522366 ↗
• MalfunctionJun 23, 2025Break; Break

  IT WAS REPORTED BY THE CUSTOMER PATIENT'S PORT TUBING SNAPPED WHILE RECEIVING HOME INFUSIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22309656 ↗
• MalfunctionJun 23, 2025Break; Break

  IT WAS REPORTED BY THE CUSTOMER PATIENT'S PORT TUBING SNAPPED WHILE RECEIVING HOME INFUSIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22309653 ↗
• MalfunctionMar 6, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY A CUSTOMER THAT A PARENT CALLED NURSE TO REPORT BLOOD LEAKING FROM PATIENT'S MEDIPORT. BLINATUMOMAB INFUSING. NURSE SAW THAT TUBING FROM MEDIPORT (ABOVE CAP) WAS CRACKED AND LEAKING BLOOD. UNABLE TO DRAW BACK BLOOD. MEDICATION PAUSED. PATIENT DE-ASSESSED AND REASSESSED. MEDICATION RESTARTED. NO HARM TO PATIENT. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 21536187 ↗
• MalfunctionNov 21, 2024Fluid/Blood Leak; Material Deformation; Fluid/Blood Leak; Material Deformation

  IT WAS REPORTED, THAT PORT ACCESSED AND HUBER NEEDLE LEAKING AT CONNECTION SITE TO CAP. ATTEMPTED TO CHANGE CAP, BUT STILL LEAKING. PORT DE-ACCESSED AND NEW NEEDLER USE. NO PATIENT HARM. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20753116 ↗
• MalfunctionJul 9, 2024Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED BY CUSTOMER THAT THE PORT NEEDLE WAS NOTED TO HAVE A HAIR/FIBER ON THE TIP OF THE NEEDLE UPON OPENING. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19707287 ↗
• InjuryJun 26, 2024Activation Problem; Activation Problem

  IT WAS REPORTED RN RECOMMEND PATIENT PORT NEEDLE AT THE END OF IMMUNOTHERAPY TREATMENT. PORT WAS A POWERLOC BARD 20G 0.75INCH NEEDLE. RN PULLED BACK, ATTEMPTING TO HAVE NEEDLE LOCK VIA SAFETY FEATURE. THE NEEDLE DID NOT LOCK INTO THE SAFETY AND RN STUCK WITH NEEDLE. NEEDLES WERE CHANGED 4-6 MONTHS AGO. THEY SEEM TO BE A LITTLE MORE FLIMSY THAN OTHERS WE USED TO USE. NO HARM REPORTED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Needle Stick/Puncture

  MAUDE report 19618020 ↗
• MalfunctionJun 6, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A NURSE ON MY TEAM DISCONNECTED A PATIENT FROM THEIR 5FU PUMP AND NOTED THAT THERE WAS WHITE POWDER ON THE PATIENTS SKIN AROUND THE PORT. WHEN HE FLUSHED THE LINE, FLUID CAME OUT AT THE TOP OF THE NEEDLE (NEAR THE BUTTERFLY WINGS). HE THEN REMOVED THE DRESSING AND DEACCESSED THE PORT-A-CATH TO CLEAN THE SITE. UNFORTUNATELY, THE PATIENT DID HAVE SOME REDNESS AT THE PORT SITE THAT WE EXPECT WITH EXPOSURE TO 5FU. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Chemical Exposure; Erythema

  MAUDE report 19479931 ↗
• MalfunctionMay 2, 2024Fluid/Blood Leak; Contamination /Decontamination Problem; Fluid/Blood Leak; Contamination /Decontamination Problem

  IT WAS REPORTED BY CUSTOMER THAT THE TWO NEEDLES THAT HAVE FLUID IN THE TUBING, NOTED UPON OPENING PRODUCT. IT WAS REPORTED THE LEAK WAS IDENTIFIED PRIOR TO PATIENT USE. IT WAS REPORTED THIS OCCURRED WITH TWO DEVICES. THIS REPORT ADDRESSES THE SECOND DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19229401 ↗
• MalfunctionMay 1, 2024Fluid/Blood Leak; Contamination /Decontamination Problem; Fluid/Blood Leak; Contamination /Decontamination Problem

  IT WAS REPORTED BY CUSTOMER THAT THE TWO NEEDLES THAT HAVE FLUID IN THE TUBING, NOTED UPON OPENING PRODUCT. IT WAS REPORTED THE LEAK WAS IDENTIFIED PRIOR TO PATIENT USE. IT WAS REPORTED THIS OCCURRED WITH TWO DEVICES. THIS REPORT ADDRESSES THE FIRST DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19222058 ↗
• MalfunctionApr 26, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY THE CUSTOMER THAT POWERLOC PORT ACCESS NEEDLE IS LEAKING FROM THE TUBING. ADDITIONAL INFORMATION RECEIVED 4/3/24: IT WAS REPORTED BY THE CUSTOMER "THE POWERLOC NEEDLE WAS PRIMED WITH SALINE AND NO ISSUE WAS NOTED. THE PATIENT'S PORT WAS ACCESSED WITH THIS NEEDLE AND IT WAS NOTED THAT FOR ABOUT EVERY 3-4 MLS OF SALINE THAT WAS FLUSHED THROUGH, 1 DROP WOULD FORM ON THE TOP OF NEEDLE AND DRIP OUT WHERE IT WASN'T SUPPOSED TO. THE NEEDLE WAS REMOVED FROM THE PATIENT AND A NEW PORT NEEDLE WAS USED TO ACCESS THE PATIENT WITHOUT ISSUE. THIS COULD HAVE BEEN AN ADVERSE EVENT SINCE THE PATIENT RECEIVED CHEMOTHERAPY THAT DAY, THOUGH THE NEEDLE WITH THE DEFECT WAS REMOVED AFTER ONLY BEING ACCESSED INTO THE PATIENT FOR A FEW SECONDS." NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19195637 ↗
• MalfunctionApr 11, 2024

  WHEN ATTEMPTING TO PRIME PORT NEEDLE, UNABLE TO PUSH FLUSH THROUGH THE LINE AS RESISTANCE WAS MET.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19087214 ↗
• MalfunctionMar 25, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED, ¿A 3/4-INCH NEEDLE BENT WHEN ACCESSING A PATIENT. THE RN ACCESSED THE PATIENT'S IMPLANTED PORT PER USUAL PROTOCOL, AND ENTERED IN THE MIDDLE OF THE PORT. ALTHOUGH THE NEEDLE WAS IN THE MIDDLE OF THE PORT, HOWEVER, IT DID NOT FLUSH. WHEN THE RN REMOVED THE HUBERT NEEDLE, SHE NOTED THAT THE NEEDLE WAS BENT. THE PATIENT EXPRESSED THAT THE ACCESS WAS MORE PAINFUL THAN USUAL, AND HE COMPLAINED THAT IT FELT SORE AFTER, WHICH IS NOT TYPICAL.¿ NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Pain

  MAUDE report 18975223 ↗
• MalfunctionFeb 14, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED ¿LOT# ASHUFC0005 THE ISSUE IS THE NEEDLE LEAKS OUT THE TOP BY THE ANGEL WINGS. OCCURS WHEN FLUSHING SALINE OR PULLING BACK BLOOD.¿ NO OTHER INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION RECEIVED 01/25/2024: IT WAS REPORTED, ¿DISCOVERED WHEN PRIMING, NO HARM TO PATIENT. NO DAMAGE TO PACKAGING OR VISUALLY ABLE TO SEE, WHEN PRIMING OR IF YOU FLUSH AFTER INSERTION, LEAKS.¿ A SPECIFIC NUMBER OF AFFECTED DEVICES OR PATIENTS WAS NOT PROVIDED BY THE COMPLAINANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18703024 ↗
• MalfunctionFeb 14, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED, "THE ISSUE IS THE NEEDLE LEAKS OUT THE TOP BY THE ANGEL WINGS. OCCURS WHEN FLUSHING SALINE OR PULLING BACK BLOOD." 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 18703023 ↗
• MalfunctionFeb 14, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED ¿LOT# ASHUFC0005 THE ISSUE IS THE NEEDLE LEAKS OUT THE TOP BY THE ANGEL WINGS. OCCURS WHEN FLUSHING SALINE OR PULLING BACK BLOOD.¿ NO OTHER INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION RECEIVED 01/25/2024: IT WAS REPORTED, ¿DISCOVERED WHEN PRIMING, NO HARM TO PATIENT. NO DAMAGE TO PACKAGING OR VISUALLY ABLE TO SEE, WHEN PRIMING OR IF YOU FLUSH AFTER INSERTION, LEAKS.¿ A SPECIFIC NUMBER OF AFFECTED DEVICES OR PATIENTS WAS NOT PROVIDED BY THE COMPLAINANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18703016 ↗
• MalfunctionFeb 14, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED, "THE ISSUE IS THE NEEDLE LEAKS OUT THE TOP BY THE ANGEL WINGS. OCCURS WHEN FLUSHING SALINE OR PULLING BACK BLOOD." 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 18703015 ↗
• MalfunctionFeb 10, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED, ¿POWERLOC SAFETY INFUSION SET HAVE LEAKED AT THE BASE OF THE NEEDLE. LUCKILY, THEY WERE CAUGHT WHILE PRIMING THE NEEDLE, PRIOR TO ACCESSING THE PATIENT.¿ NO OTHER INFORMATION WAS PROVIDED. IT WAS REPORTED THIS OCCURRED WITH TWO DEVICES. THIS REPORT ADDRESSES THE SECOND DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18682679 ↗
• MalfunctionFeb 10, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED, ¿POWERLOC SAFETY INFUSION SET HAVE LEAKED AT THE BASE OF THE NEEDLE. LUCKILY, THEY WERE CAUGHT WHILE PRIMING THE NEEDLE, PRIOR TO ACCESSING THE PATIENT.¿ NO OTHER INFORMATION WAS PROVIDED. IT WAS REPORTED THIS OCCURRED WITH TWO DEVICES. THIS REPORT ADDRESSES THE FIRST DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18682678 ↗