Port Access Kit PA-0031Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00801741085529), received between Nov 7, 2018 and Nov 20, 2025 — classified as 1 injury, 8 malfunctions.

The most frequently reported specific device problem is “Contamination /Decontamination Problem” (3 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 18, 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-2666-2020 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 20, 2025Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  IT WAS REPORTED IMMEDIATELY AFTER PERFORMING A NEEDLELESS CONNECTION DEVICE CHANGE ON A HUBER NEEDLE WHEN FLUSHING THE LINE SALINE WAS LEAKING, SO ANOTHER CONNECTOR WAS PLACED, AND THE LEAK WAS STILL PRESENT. AFTER THAT IT WAS SURMISED THAT THE DISTAL CONNECTION ON THE HUBER NEEDLE TUBING WAS DAMAGED. THE HUBER NEEDLE WAS CHANGED AFTER THAT, AND THE CONNECTOR WAS CRACKED. THIS HUBER NEEDLE WAS PLACED ON TUESDAY, 10/28, AND HAS HAD THE NEEDLELESS CONNECTOR CHANGED EVERY 12 HOURS BECAUSE PROPOFOL HAS BEEN BEING INFUSED THROUGH THAT LINE. THE ISSUE OF LEAKING HAS NEVER BEEN NOTICED UNTIL THIS EVENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23605847 ↗
• MalfunctionJul 31, 2025Material Deformation; Material Deformation

  IT WAS REPORTED, PATIENT ARRIVED TO OUTPATIENT INFUSION CLINIC TO HAVE THEIR 5-FU PUMP REMOVED AND CENTRAL VENOUS ACCESS SITE FLUSHED. PATIENT ARRIVED TO INFUSION SUITE VIA AMBULATION AND DENIED COMPLAINTS AT THIS TIME. 5FU PUMP BALL APPEARS DEFLATED. PUMP DISCONNECTED AND LINE FLUSHED WITH 20ML NS PER PROTOCOL WITHOUT INCIDENT. WHILE RN ATTEMPTED TO DE-ACCESS PORT HUBER NEEDLE; RESISTANCE WAS NOTED TOWARD THE END OF THE NEEDLE AND PATIENT VERBALIZED EXTREME DISCOMFORT. HEALTHCARE PROFESSIONAL CAME TO CHAIRSIDE TO EVALUATE; PER NP, "GO TO THE EMERGENCY DEPARTMENT." PATIENT VERBALIZED UNDERSTANDING AND AGREED TO GO TO EMERGENCY DEPARTMENT FOR FURTHER EVALUATION. PORT SITE + HUBER NEEDLE STABILIZED WITH GAUZE ABD DRESSING + TAPE. ED NOTIFIED VIA TELEPHONE OF PATIENT'S CONDITION. PATIENT LEFT INFUSION SUITE INDEPENDENTLY WITH STEADY GATE. NURSES EXPLAINED THAT PATIENT SAID THAT HE ROLLED ON THE NEEDLE WHEN SLEEPING. CAME INTO HOSPITAL WITH THE PORT NEEDLE LOOKING TO BE ALMOST PULLED OUT AND EXPERIENCED INTENSE DISCOMFORT WHEN DE-ACCESSING.

  Patient problems: Discomfort

  MAUDE report 22677286 ↗
• MalfunctionMay 10, 2024Defective Component; Contamination /Decontamination Problem; Defective Component; Contamination /Decontamination Problem

  IT WAS REPORTED BY THE CUSTOMER RN WAS ACCESSING PORTACATH, OPENED A BARD KIT TO USE. WHEN SHE PEELED THE BACKING OF THE ADHESIVE DRESSING, TWO RNS NOTICED A WHITE SPOT ON THE INSIDE OF THE DRESSING/STICKY SIDE. A NEW DRESSING WAS OPENED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19288299 ↗
• MalfunctionNov 20, 2023Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED BY THE CUSTOMER OPENED A PORT KIT AND INSIDE THE STERILE PACKAGE WAS A LONG BLACK HAIR THAT WAS UNDER SUPPLIES. ADDITIONAL INFORMATION RECEIVED 11/3/2023: IT WAS REPORTED THERE WAS NO NEGATIVE OUTCOME OR INJURY AND A NEW PRODUCT WAS USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18171025 ↗
• InjuryApr 10, 2023Activation Problem; Activation Problem

  IT WAS REPORTED BY THE CUSTOMER, I JUST WANT TO MAKE YOU AWARE THAT WE USE THE SAFE STEP HUBER NEEDLE SET PORT ACCESS KIT IN OUR INFUSION CLINIC. UNFORTUNATELY, ONE OF OUR NURSES RN, HAD A NEEDLE STICK INJURY. SHE DE-ACCESSED A PATIENT'S PORT, THE SAFETY FEATURE DID NOT ENGAGE AND WHEN PATIENT LET GO FROM HOLDING HIS NECKLINE, RN GOT STUCK ON HER MIDDLE FINGER. NO PATIENT HARM. HOWEVER, I HAD TO RECALL THE PATIENT TO COME BACK TO HAVE LABS DRAWN SINCE HE ALREADY LEFT WHEN I FOUND OUT ABOUT THE INCIDENT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Needle Stick/Puncture

  MAUDE report 16706917 ↗
• MalfunctionSep 8, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED "THERE IS A HAIR INSIDE THE STERILE PACKAGE.¿ NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12442379 ↗
• MalfunctionNov 11, 2019Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED VIA MEDWATCH "PATIENT ARRIVED FOR CHEMO DISCONNECT, NOTICED WHITE POWDER TYPE SUBSTANCE/RESIDUE ON PORT EXTENSION AND PATIENT'S CHEST/BREAST AREA. SUBSTANCE APPEARED TO BE CRYSTALIZED 5 FU CHEMO. WHEN PORT WAS FLUSHED WITH NS AND HEPARIN IT LEAKED VIA THE Y SITE VALVE. PATIENT CALLED WHEN HE ARRIVED HOME AFTER CHECKING SHIRT HE WORE PREVIOUS DAY AND THAT ALSO HAD WHITE RESIDUE ON IT."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9306172 ↗
• MalfunctionSep 24, 2019Leak/Splash

  PATIENT ARRIVED FOR CHEMO DISCONNECT, NOTICED WHITE POWDER TYPE SUBSTANCE/RESIDUE ON PORT EXTENSION AND PATIENT'S CHEST/BREAST AREA. SUBSTANCE APPEARED TO BE CRYSTALIZED 5 FU CHEMO. WHEN PORT WAS FLUSHED WITH NS AND HEPARIN, IT LEAKED VIA THE Y SITE VALVE. PATIENT CALLED WHEN HE ARRIVED HOME AFTER CHECKING SHIRT HE WORE PREVIOUS DAY AND THAT ALSO HAD WHITE RESIDUE ON IT.

  Patient problems: Chemical Exposure

  MAUDE report 9109131 ↗
• MalfunctionNov 7, 2018Detachment of Device or Device Component

  THE DEVICE EXHIBITED A DETACHED NEEDLE HOUSING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8047658 ↗