Port Access Kit 2142075Recalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 00801741044298), received between Dec 22, 2016 and Apr 23, 2026 — classified as 3 injuries, 25 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (12 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-2662-2020 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 28 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 23, 2026Fluid/Blood Leak; Material Deformation

  IT WAS REPORTED BY MEDWATCH THE PATIENT CAME TO CLINIC FOR VENOFER INFUSION. PATIENT'S PORT WAS ACCESSED. PATIENT WAS ABOUT AN 1.5 HOURS INTO THE VENOFER INFUSION WHEN A SMALL AMOUNT OF LIQUID WAS NOTED ON HIS SHIRT. THE LEAKING WAS COMING FROM WHERE THE CLAVE CONNECTS TO THE PORT ITSELF. PATIENT WAS FINISHED WITH THE VENOFER AND SALINE WAS INFUSING FOR THE NEXT 30 MINUTES. THE TUBING WAS WRAPPED WITH GAUZE WITH MINIMAL DRAINAGE. PORT WAS THEN DE-ACCESSED. NO FURTHER ISSUES NOTED. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24966308 ↗
• MalfunctionMar 25, 2026Fluid/Blood Leak

  IT WAS REPORTED BY THE CUSTOMER THAT THIS MORNING THERE WAS A LEAK AT THE EXTENSION LINE CONNECTING TO THE CLAVE. CLAVE CHANGED OUT AND COULD NOT SEE ANY LEAKING AT FIRST. THEN, LEAKING DID OCCUR. PATIENT GETTING HYDRATION AND ELECTROLYTES INFUSED. STOPPED INFUSION, DE-ACCESSED AND THEN RE-ACCESSED PATIENT WITH NEW PORT, DIFFERENT LOT NUMBERS, AND NO ISSUES AT THIS TIME. RESULTED IN THE NEED FOR INCREASED MONITORING NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24683380 ↗
• MalfunctionMar 11, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT THE WHEN THE IV LINE/MEDICATION WAS HOOKED UP TO THE PATIENT, THE CONNECTOR STARTED TO LEAK. THE CONNECTOR WAS THEN REPLACED THREE TIMES WITH THE SAME RESULTS. THE PORT NEEDLE WAS THEN DE-ACCESSED AND RE-ACCESSED WITH A NEW NEEDLE. THIS RESOLVED THE PROBLEM AND THERE WAS NO MORE LEAKING. THE FLUIDS THAT LEAKED WERE NOT CHEMOTHERAPY, JUST NS AND SOME ANTINAUSEA MEDICATION. REACHED THE INDIVIDUAL BUT DID NOT CAUSE HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24575330 ↗
• MalfunctionMar 10, 2026Fluid/Blood Leak; Product Quality Problem

  IT WAS REPORTED BY CUSTOMER THAT IT WAS LEAKING OCCURRED AT THE CONNECTOR SITE. AFTER STARTING HYDRATION ON PATIENT VIA PORT, LEAKING OCCURRED AT THE CONNECTOR SITE. REACHED THE INDIVIDUAL BUT DID NOT CAUSE HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24565286 ↗
• MalfunctionMar 10, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT WHILE RUNNING HYDRATION IT AS NOTICED PORT TUBING WAS LEAKING ABOVE CLAVE CONNECTION POINT NO MATTER HOW TIGHT THE CLAVE WAS. NO FURTHER DETAILS AVAILABLE OR PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24565283 ↗
• MalfunctionMar 10, 2026Fluid/Blood Leak

  IT WAS REPORTED PATIENT WAS RUNNING GEMZAR AND WHILE IN THE BATHROOM SHE NOTICED DRIPS ON THE FLOOR, CHEMO AND NS WERE STOPPED. CHEMO TUBING WAS LEAKING FROM THE BLUE LOADING PIECE ABOVE THE PUMP SEGMENT OF TUBING. PATIENT WAS DISCONNECTED AND A SPILL KIT WAS USED TO CLEAN UP PUMP AND BATHROOM; NONE REACHED THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24559407 ↗
• MalfunctionMar 10, 2026Fluid/Blood Leak

  IT WAS REPORTED PATIENT CAME TO CLINIC FOR ABRAXANE INFUSION VIA PORT. PATIENT'S PORT WAS ACCESSED. NO LEAKING NOTED DURING THE INFUSION, BUT WITH FLUSHING THE PORT AFTER THE INFUSION, IT WAS NOTED THAT FLUID WAS LEAKING WHERE THE CLAVE CONNECTS ON TO THE END OF THE PORT TUBING. THE LEAKING ONLY HAPPENED WITH FLUSHING THE PORT WITH SALINE, NOT DURING THE CHEMO TREATMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24559255 ↗
• MalfunctionJul 23, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED OUTPATIENT INFUSION UNIT OPENED A BRAND-NEW STERILE PORT KIT AND FOUND A HAIR IN THE KIT AS SOON AS IT WAS OPENED. WE WERE UNABLE TO USE THIS KIT DUE TO ITS COMPROMISED STERILITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22577779 ↗
• MalfunctionJun 13, 2025Unsealed Device Packaging; Tear, Rip or Hole in Device Packaging; Unsealed Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED BY THE CUSTOMER UPON OPENING THE BOX WITH 5 PORT ACCESS KITS, THEY APPEARED TO HAVE ALREADY BEEN BREACHED AND TAMPERED WITH. WITH THE ATTACHED SYRINGE, THEY ALSO APPEARED BENT AND WITH DAMAGED PUSH DOWN PLUNGE. THE BOX THEY CAME IN WAS NOT DAMAGED AND WAS SEALED WITH NO SIGNS OF LOOSE TAPE. THE ITEM WAS CAUGHT BEFORE REACHING THE FLOOR AND DID NOT AFFECT PATIENT CARE. THIS REPORT ADDRESSES ALL 5 PORT ACCESS KITS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22205315 ↗
• MalfunctionApr 24, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED "I HAD ACCESSED THE PATIENT'S IMPLANTED PORT WITH OUR REGULAR PORT ACCESS KIT HUBER NEEDLE. AFTER ACCESSING, I FLUSHED THE LINE AND THE PATIENT STATED SHE FELT SOME SALINE DRIP DOWN HER CHEST, I FLUSHED AGAIN AND REALIZED THE SALINE WAS LEAKING OUT THE TOP OF THE HUBER NEEDLE. I DEACCESSED THE PATIENT AND FLUSHED THE LINE AGAIN WHILE IT WAS NOT CONNECTED TO THE PATIENT AND SALINE WAS STILL LEAKING OUT THE TOP OF THE HUBER. HUBER NEEDLE CAME FROM THE PORT ACCESS KIT." NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21903855 ↗
• MalfunctionFeb 7, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED BY THE CUSTOMER, "THE DRESSING PROVIDED IN THE PORT ACCESS KITS DON'T SEEM TO ADHERE AND WE ARE HAVING TO USE IV START KIT DRESSINGS TO RE-ENFORCE THE PORT DRESSING. AS A RESULT, THE PORT DRESSINGS ARE NOT ALL APPLIED IN THE SAME CONSISTENT MANNER." ADDITIONAL INFORMATION RECEIVED 2/3/2025: IT WAS REPORTED BY THE CUSTOMER, "THE DRESSINGS ARE BEING DIFFICULT TO REMOVE FROM THE NEEDLE. TWO DIFFERENT PORTS WERE REVIEWED WITHIN 24 HOURS OF BEING ACCESSED AND THE FIRST ONE, THE TUBING SIDE OF THE PORT STARTED TO PEEL AND THE SECOND ONE THE NEEDLE WAS EXPOSED AS A RESULT OF THE DRESSING HAVING PEELED OFF." IT WAS REPORTED THIS OCCURRED WITH TWO DEVICES. THIS REPORT ADDRESSES BOTH DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21335254 ↗
• MalfunctionJan 31, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED BY THE CUSTOMER, "THE DRESSING PROVIDED IN THE PORT ACCESS KITS DON'T SEEM TO ADHERE AND WE ARE HAVING TO USE IV START KIT DRESSINGS TO RE-ENFORCE THE PORT DRESSING. AS A RESULT THE PORT DRESSINGS ARE NOT ALL APPLIED IN THE SAME CONSISTENT MANNER." THE CUSTOMER STATES THIS IS AN "ONGOING EVENT" BUT DID NOT PROVIDE A SPECIFIC QUANTITY OF OCCURRENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21285261 ↗
• MalfunctionDec 30, 2024Activation Problem; Activation Problem

  IT WAS REPORTED VIA MEDWATCH "PORT WAS ACCESSED WITH A 20G 3/4" NEEDLE FROM THE PAC ACCESS KIT. WHEN DE-ACCESSING THE PORT, I ATTEMPTED TO RETRACT THE NEEDLE INTO THE SAFETY DEVICE AS EXPECTED. THE NEEDLE CAME ALL THE WAY THROUGH THE SAFETY DEVICE AND BROKE COMPLETELY FROM THE BASE. THERE WAS NO NEEDLE STICK INJURY TO THE EMPLOYEE. NEEDLE USED TO ADMINISTER CHEMOTHERAPY."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21043378 ↗
• MalfunctionDec 4, 2024Activation Problem; Activation Problem

  IT WAS REPORTED BY CUSTOMER THAT THE GREEN NEEDLE SAFETY CONTINUES TO SLIDE OFF AND NOT SAFETY THE NEEDLE TIP AFTER USE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20848370 ↗
• MalfunctionMar 21, 2023Defective Component; Defective Component

  IT WAS REPORTED BY THE CUSTOMER THAT THEY HAVE TRANSITIONED FROM A CUSTOM KIT TO THE STANDARD KIT (2142075). DURING THAT TIME (1 MONTH) THEY HAVE HAD SEVERAL PAIRS OF GLOVES THAT BREAK APART EASILY. NO OTHER INFORMATION WAS PROVIDED. THE CUSTOMER DID NOT GIVE A SPECIFIC QUANTITY OF AFFECTED PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16588088 ↗
• MalfunctionMar 7, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED PRODUCT LEAK AND CRACK IN THE EXTENSION SET. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11426596 ↗
• MalfunctionMar 19, 2020Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT A PORT KIT WAS OPENED AT BEDSIDE TO ACCESS PATIENT'S PORT AND A BROWN FLAKE WAS FOUND WITHIN IN THE PACKAGING.

  Patient problems: No Patient Involvement

  MAUDE report 9856396 ↗
• MalfunctionAug 17, 2018Break

  THE FACILITY REPORTED THE RN NOTED THAT BLOOD WAS ON THE BED AND WHEN SHE LOOKED CLOSER, SHE NOTICED THAT THE LINE HAD BROKEN AT THE PART WHERE THE LINE MEETS UP WITH THE CLAVE. IT WAS STATED THAT THE PATIENT WAS PUT AT INCREASED RISK OF INFECTION. RN HAD TO DEACCESS LINE AND RE-ACCESS IT.

  Patient problems: Unspecified Infection

  MAUDE report 7792512 ↗
• MalfunctionAug 16, 2018Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE NURSE NOTICED THE HAIR IN THE PACKAGE BEFORE ACCESSING THE PATIENT. THE KIT WAS NEVER OPENED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7792035 ↗
• MalfunctionJun 8, 2018Crack

  IT WAS REPORTED THAT THIS DEVICE WAS REMOVED FROM THE SUPPLY CABINET FOR QUALITY TESTING PURPOSES; IT WAS NEVER USED ON A PATIENT. AFTER BEING MANIPULATED FOR A FEW MINUTES, THE DISTAL END OF THE TUBING WHERE IT ATTACHES TO THE LUERLOCK CONNECTOR CRACKED.

  Patient problems: No Patient Involvement

  MAUDE report 7584364 ↗
• MalfunctionJun 8, 2018Crack; Fluid/Blood Leak

  IT WAS REPORTED THAT ON THE SIXTH DAY AFTER THE PORT WAS ACCESSED, THE DEVICE STARTED LEAKING. IT WAS NOTED THERE WAS A CRACK IN THE DISTAL END OF THE TUBING WHERE IT ATTACHES TO THE LUERLOCK CONNECTOR. PORT WAS RE-ACCESSED USING A NEW DEVICE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7584359 ↗
• MalfunctionJun 4, 2018Crack; Fluid/Blood Leak

  IT WAS REPORTED THAT ON THE THIRD DAY AFTER THE PORT WAS ACCESSED, THE DEVICE STARTED LEAKING. IT WAS NOTED THERE WAS A CRACK IN THE DISTAL END OF THE TUBING WHERE IT ATTACHES TO THE LUERLOCK CONNECTOR. PORT WAS RE-ACCESSED USING A NEW DEVICE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7567523 ↗
• MalfunctionMay 30, 2018Crack; Leak/Splash

  IT WAS REPORTED THAT ON THE SIXTH DAY AFTER THE PORT WAS ACCESSED, THE DEVICE STARTED LEAKING. IT WAS NOTED THERE WAS A CRACK IN THE DISTAL END OF THE TUBING WHERE IT ATTACHES TO THE LUERLOCK CONNECTOR. PORT WAS RE-ACCESSED USING A NEW DEVICE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7555322 ↗
• MalfunctionMay 30, 2018Crack; Fluid/Blood Leak

  IT WAS REPORTED THAT ON THE FOURTH DAY AFTER THE PORT WAS ACCESSED THE DEVICE STARTED LEAKING. IT WAS NOTED THERE WAS A CRACK IN THE DISTAL END OF THE TUBING WHERE IT ATTACHES TO THE LUERLOCK CONNECTOR. PORT WAS RE-ACCESSED USING A NEW DEVICE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7555258 ↗
• MalfunctionMay 30, 2018Crack

  IT WAS REPORTED THAT THIS DEVICE WAS REMOVED FROM THE SUPPLY CABINET FOR QUALITY TESTING PURPOSES; AND IT WAS NEVER USED ON A PATIENT. AFTER BEING MANIPULATED FOR A FEW MINUTES, THE DISTAL END OF THE TUBING WHERE IT ATTACHES TO THE LUERLOCK CONNECTOR CRACKED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7555249 ↗