Port Access Needle 0142075Recalls & reported problems

Summary

The FDA's MAUDE database contains 307 adverse event reports that list this exact device (DI 00801741047466), received between Aug 22, 2018 and Aug 25, 2026 — classified as 4 injuries, 303 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (219 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 25 most recent of 307 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 25, 2026Material Twisted/Bent; Activation Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50442689 ↗
• MalfunctionApr 1, 2026Activation Problem

  IT WAS REPORTED THAT BASE DETACHED FROM THE NEEDLE. THERE WAS NOT A NEEDLE STICK INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24758845 ↗
• MalfunctionNov 19, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY THE CUSTOMER THAT A LEAK WAS DETECTED IN THE PAC TUBE AT THE INFUSION SITE. NO PATIENT INJURY WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23597631 ↗
• MalfunctionNov 12, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED PER NURSING REPORT, IT WAS LEAKING FLUID AND AIR AT HUB. THE NURSE CHANGED THE NEEDLELESS CONNECTOR WHICH DID NOT FIX THE ISSUE. THE NEEDLE WAS DE-ACCESSED AND A NEW ONE WAS USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23534936 ↗
• MalfunctionNov 4, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED HOLE IN PORT ACCESS NEEDLE WHICH CAUSE LEAKAGE WHEN FLUSHING. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23469673 ↗
• MalfunctionNov 4, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED HOLE IN PORT ACCESS NEEDLE WHICH CAUSE LEAKAGE WHEN FLUSHING. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23469660 ↗
• MalfunctionNov 4, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED LEAKAGE AT THE DISTAL JUNCTION (PART WHERE THE TUBING IS LINKED). NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23467442 ↗
• MalfunctionOct 28, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED PORT ACCESS NEEDLE CRACK AT THE JOINT, CAUSING BACKFLOW OF BLOOD FROM PORT SITE. PATIENT WAS NOT HARMED. IT WAS REPORTED THIS OCCURRED WITH TWO DEVICES. THIS REPORT ADDRESSES BOTH DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23410026 ↗
• MalfunctionAug 15, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY THE CUSTOMER THE POWERLOC MAX HUBER NEEDLE INFUSION SET TUBING IS CRACKED ON MULTIPLE OCCASIONS. THE MEDICATION ADMINISTERED HAS VARIED AND HAS ONLY OCCURRED ON POWERLOC MAX AT THIS FACILITY, OVER A YEAR AT LEAST, AND TYPICALLY OCCURS ON PATIENTS YOUNGER THAN 7. THIS RESULTED IN BLOOD LOSS AND THE NEED TO RE-ACCESS THE PORT. IT WAS REPORTED THIS OCCURRED WITH TWO PATIENTS. THIS REPORT ADDRESSES BOTH PATIENTS.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 22814826 ↗
• MalfunctionAug 12, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY CUSTOMER THAT THERE WAS A LEAK IN THE TUBING AT THE CONNECTION POINT OF THE TUBE AND BLUE HUB ON TUBING. THERE WAS A LEAK IN HAZARDOUS DRUG PUTTING CLINICIANS AND PATIENT AT RISK.

  Patient problems: Chemical Exposure

  MAUDE report 22790043 ↗
• MalfunctionJul 30, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY THE CUSTOMER THAT THE TUBING AT THE END OF THE PORT NEEDLE CLOSE TO THE CLAVE STARTED LEAKING, BLOOD SPILLED THROUGH THE LEAK IN THE TUBING, AS WELL AS THE BICARB FLUID THAT WAS INFUSING. A HOLE WAS LOCATED IN THE TUBING NEAR THE CLAVE. NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22667873 ↗
• MalfunctionJul 3, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE POWERLOC MAX INFUSION SET TUBING IS CRACKED, RESULTING IN BLOOD LOSS.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 22395469 ↗
• MalfunctionJun 24, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY THE CUSTOMER "PATIENT WAS RUNNING A BLOOD TRANSFUSION THROUGH HIS IVAD. AT THE END OF THE INFUSION, PATIENT NOTIFIED RN THAT HE HAD BLOOD ON HIM. RN PAUSED INFUSION AND CHECKED TUBING, CONNECTION BETWEEN TUBING AND MICROCLAVE CAP, AND CONNECTION BETWEEN MICROCLAVE CAP AND LINE. THE LEAKAGE WAS NOTED TO BE BETWEEN THE MICROCLAVE CAP AND THE LINE. PROVIDER NOTIFIED. NO PATIENT HARM, INJURY, COMPLICATION, OR NEGATIVE OUTCOME AS A RESULT. OUR TEAM IS NOT SURE IF THIS IS A CONNECTION ISSUE BETWEEN THE HUB AT THE DISTAL END OF THE IVAD TUBING OR WITH THE MICROCLAVE SOMEHOW. THE PATIENT WAS ACCESSED, FLUSHED, BLOOD INFUSION AND WHEN IT WAS FINISHING UP BLOOD WAS LEADING OUT OF THE CONNECTION OF MICROCLAVE/HUB. IT DOES NOT APPEAR TO BE LEAKING FROM BELOW THE HUB/WHERE THE CRACKS WERE OCCURRING IN THE PREVIOUS IVAD PRODUCT.".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22323807 ↗
• MalfunctionJun 23, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED VIA MEDWATCH THE CUSTOMER HAS EXPERIENCED MULTIPLE EVENTS WITH THE PORT BREAKING. THE ORIGINAL INTENDED PROCEDURE IS IMMUNOTHERAPY ADMINISTRATION. THERE WAS NO HARM TO THE PATIENT. IT WAS REPORTED THIS OCCURRED WITH FOUR DEVICES. THIS REPORT ADDRESSES ALL FOUR DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22310875 ↗
• MalfunctionJun 19, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY THE CUSTOMER THE POWERLOC MAX HUBER NEEDLE INFUSION SET TUBING IS CRACKED ON MULTIPLE OCCASIONS. THE MEDICATION ADMINISTERED HAS VARIED AND HAS ONLY OCCURRED ON POWERLOC MAX AT THIS FACILITY, OVER A YEAR AT LEAST, AND TYPICALLY OCCURS ON PATIENTS YOUNGER THAN 7. THIS RESULTED IN BLOOD LOSS AND THE NEED TO RE-ACCESS THE PORT. IT WAS REPORTED THIS OCCURRED WITH TWO PATIENTS. THIS REPORT ADDRESSES BOTH PATIENTS.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 22292758 ↗
• MalfunctionJun 19, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY THE CUSTOMER THE POWERLOC MAX HUBER NEEDLE INFUSION SET TUBING IS CRACKED. THE PATIENT IS REPORTED TO BE YOUNGER THAN 7. THIS RESULTED IN BLOOD LOSS DUE TO AN OPEN SYSTEM AND THE NEED TO RE-ACCESS THE PORT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 22289535 ↗
• MalfunctionMay 12, 2025Activation Problem; Activation Problem

  IT WAS REPORTED THAT THE PORT NEEDLE THAT WOULD NOT ENGAGE THE SAFETY WHEN DE-ACCESSING. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22005918 ↗
• MalfunctionMar 31, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY THE CUSTOMER; THE PATIENT WAS RECEIVING ARSENIC INFUSION. WHEN THE TUBING ON THE NEEDLE CRACKED IT CAUSED BLOOD TO BACK OUT OF LINE. THE NEEDLE HAD TO BE REMOVED, A BLOOD CULTURE HAD TO BE OBTAINED, AND THE PATIENT DID NOT RECEIVE THE LAST 18 MINUTES OF THE INFUSION SINCE IT WAS ALMOST FINISHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21733145 ↗
• MalfunctionFeb 26, 2025Activation Problem; Activation Problem

  IT WAS REPORTED BY THE CUSTOMER, WHEN DE-ACCESSING THE PATIENT¿S POWER PORT, THE NEEDLE SAFETY APPARATUS DID NOT ENGAGE AND SLIDE DOWN THE NEEDLE. THEREFORE, THE NEEDLE HAD TO BE PULLED OUT OF THE PORT BY HOLDING THE PORT RATHER THAN THE FACE PLATE OF THE PORT NEEDLE. ADDITIONAL INFORMATION RECEIVED FEBRUARY 13, 2025: IT WAS REPORTED THERE WAS NO SERIOUS INJURY OCCURRED TO STAFF OR THE PATIENT BESIDES MILD DISCOMFORT TO THE PATIENT WHEN THE NEEDLE WAS REMOVED. DEVICE WAS DISCARDED AFTER EVENT.

  Patient problems: Discomfort

  MAUDE report 21471839 ↗
• MalfunctionFeb 26, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY THE CUSTOMER THEY HAD A BROKEN NEEDLE. ADDITIONAL INFORMATION RECEIVED ON 02/04/2025: IT WAS REPORTED BY THE CUSTOMER, NEEDLE BROKE ON DAY 5 OF ACCESS. PATIENT WAS BLEEDING FROM THE PORT TUBING AND HAD TO BE IMMEDIATELY CLAMPED, DEACCESSED, AND REACCESSED TO CONTINUE POST-HYDRATION FOR CHEMOTHERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21471068 ↗
• MalfunctionFeb 19, 2025Break; Break

  IT WAS REPORTED VIA MEDWATCH "BARD POWERLOC MAX 20G 0.75IN NEEDLE CRACKED AND BROKE AT THE LUER LOCK AT DISTAL END OF PORT NEEDLE WHILE PATIENT PORT WAS ACCESSED AND HEPARIN LOCKED. RESULTED IN IMMEDIATE CLAMPING AND DE-ACCESSING OF PORT A CATH."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21417096 ↗
• MalfunctionFeb 19, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED PORT CATH NEEDLE TUBING BEGAN LEAKING BLOOD AND FLUID FROM CONNECTION POINT ABOVE NAD. NEEDLE NEEDED TO BE RE-ACCESSED. OCCURRED WHILE IN USE WITH PATIENT. NO INJURY, HARM OR DEATH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21415069 ↗
• MalfunctionFeb 6, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED NEEDLE BROKE WHILE ACCESSED IN PATIENT¿S PAC. NEEDLE HAD TO BE IMMEDIATELY AND EMERGENTLY REMOVED TO AVOID COMPLICATIONS. BLEEDING NOTED BACK FROM HOLE IN TUBING. CHEMOTHERAPY EMERGENTLY STOPPED. NEEDLE REMOVED. PATIENT RE-ACCESSED WITH A NEW NEEDLE. INTERRUPTION AND DELAY IN CHEMOTHERAPY ADMINISTRATION. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21328907 ↗
• MalfunctionFeb 3, 2025Break; Break

  IT WAS REPORTED BY CUSTOMER THAT THE NEEDLE BROKE WHILE ACCESSED IN PATIENT¿S PAC. NEEDLE HAD TO BE IMMEDIATELY AND EMERGENTLY REMOVED TO AVOID COMPLICATIONS. PORT WAS DE-ACCESSED USING THE SAFETY MECHANISM. THERE WAS NO ADVERSE EVENT APART FROM BLEEDING AND AN UNPLANNED DE-ACCESS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21289477 ↗
• MalfunctionJan 18, 2025Activation Problem; Activation Problem

  IT WAS REPORTED BY MEDWATCH THAT PATIENT WAS HERE TO HAVE LABS DRAWN VIA HER PORT, SO PORT WAS ACCESSED, LABS DRAWN, AND PORT FLUSHED PER PROTOCOL. HOWEVER, UPON TRYING TO DE-ACCESS THE HUBER NEEDLE, THE SAFETY DEVICE WOULDN'T ENGAGE AND LET THE NEEDLE RETRACT, SO IT MANUALLY HAD TO BE PULLED OUT. NO HARM TO THE PATIENT OCCURRED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21186685 ↗