Port Access Needle 0142010Recalls & reported problems

Summary

The FDA's MAUDE database contains 37 adverse event reports that list this exact device (DI 00801741047442), received between May 9, 2018 and Jan 23, 2026 — classified as 1 injury, 36 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (22 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. How this data works · Data updated Oct 13, 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 · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 37 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 23, 2026Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED, PRODUCT IS DAMAGED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24163497 ↗
• MalfunctionJan 7, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT THE 20 GAUGE 1 INCH NEEDLE HAD A HOLE IN THE TUBING, AND IT WAS LEAKING. I FLUSHED THE LINE AND SALINE WENT EVERYWHERE. I DID A NEEDLE AND DRESSING CHANGE AFTER. PATIENT IS ALREADY ON 3 ANTIBIOTICS. NO FURTHER DETAILS AVAILABLE OR PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23994280 ↗
• MalfunctionJan 6, 2026Activation Problem

  IT WAS REPORTED THAT THE SAFETY MECHANISM TRIGGERS TOO EASILY, SOMETIMES AS SOON AS IT IS PLACED. PRODUCT GENERALLY VERY WOBBLY AND APPEARS VERY UNSTABLE TO THE CUSTOMER. NO FURTHER DETAILS AVAILABLE OR PROVIDED. NO PATIENT OR USER HAS BEEN HARMED. A SPECIFIC NUMBER OF AFFECTED DEVICES OR PATIENTS WAS NOT PROVIDED BY THE COMPLAINANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23975305 ↗
• MalfunctionJan 5, 2026Material Deformation

  IT WAS REPORTED, THE HOSE REMAINS PERMANENTLY KINKED AFTER CLAMPING, SO THAT THE FLOW IS DISTURBED. THIS OCCURRED WITH THREE DEVICES. THIS REPORT ADDRESSES ALL THREE DEVICES. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23957616 ↗
• MalfunctionJan 5, 2026Product Quality Problem

  IT WAS REPORTED THAT THE POWERLOC MAX IS VERY WOBBLY. IT WAS REPORTED THIS OCCURRED WITH THREE DEVICES. THIS REPORT ADDRESSES ALL THREE DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23957597 ↗
• MalfunctionJun 10, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE POWERLOC MAX HUBER NEEDLE INFUSION SET TUBING IS CRACKED. THE MEDICATION BEING ADMINISTERED THROUGH THE HUBER NEEDLE'S HAS VARIED. THIS HAS ONLY OCCURRED WITH POWERLOC MAX AT THE FACILITY. TYPICALLY OCCURS ON PATIENTS YOUNGER THAN 7. PATIENT HAD BLOOD LOSS DUE TO AN OPEN SYSTEM AND THE NEED TO RE-ACCESS THE PORT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22181466 ↗
• MalfunctionJun 10, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE POWERLOC MAX HUBER NEEDLE INFUSION SET TUBING IS CRACKED. THE MEDICATION BEING ADMINISTERED THROUGH THE HUBER NEEDLE'S HAS VARIED. THIS HAS ONLY OCCURRED WITH POWERLOC MAX AT THE FACILITY. TYPICALLY OCCURS ON PATIENTS YOUNGER THAN 7. PATIENT HAD BLOOD LOSS DUE TO AN OPEN SYSTEM AND THE NEED TO RE-ACCESS THE PORT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22181462 ↗
• MalfunctionNov 24, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY MEDWATCH THAT NEEDLE CRACKED AND BROKE AT LUER LOCK AT DISTAL END OF PORT NEEDLE DURING IV FLUID ADMINISTRATION DURING INPATIENT HOSPITALIZATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20767586 ↗
• MalfunctionOct 9, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT POWERLOC MAX NEEDLE TUBING BREAKING / CRACKING AT THE DISTAL END OF THE TUBING WHERE IT MEETS THE LUER LOCK HUB. INCIDENT OCCURRED ON DAY 4 OF AN INFUSION OF CONTINUOUS CHEMOTHERAPY. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20409716 ↗
• MalfunctionJun 25, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT PORT WAS PLACED IN OR AND ACCESSED IN OR ON (B)(6) 2024. VALGUARD COVERED THE TUBING OUT FROM THE NEEDLE. (B)(6) RN NOTICED FLUID LEAKING IN VALGUARD; HOLE IN TUBING BELOW CONNECTION PIECE. PORT BEING KEPT BY RISK UNTIL PATIENT IS OUT 4 WEEKS AND INFECTION FREE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19606066 ↗
• InjuryJun 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY CUSTOMER THAT, "CALLER STATES HE HAS A PATIENT WHO THEY ACCESS WITH PRODUCT CODE 0142010 AND SHE IS HAVING A RASH AFTER ACCESS. CALLER STATES THEY HAVE TRIED TO CHANGE THE TYPE OF BANDAGE AND CLEANING SOLUTION BUT THE RASH CONTINUES. CALLER STATES THE PATIENT HAS A NICKEL ALLERGY. RESPONSE: EXPLAINED THAT THE PRODUCT CODE 0142010 HAS A NEEDLE MADE WITH STAINLESS STEEL AND STAINLESS STEEL DOES CONTAIN SOME NICKEL." ADDITIONAL INFORMATION RECEIVED 06/11/2024: NO MEDICAL INTERVENTION WAS NEEDED TO TREAT THE ALLERGIC REACTION.

  Patient problems: Rash

  MAUDE report 19567285 ↗
• MalfunctionMay 9, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY CUSTOMER THAT PORT LINE WAS LEAKING JUST PASSED THE CONNECTOR. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19281142 ↗
• MalfunctionNov 22, 2023Activation Problem; Activation Problem

  IT WAS REPORTED BY THE CUSTOMER THAT WHILE DE-ACCESSING A PATIENT'S PORT, THE BASE OF THE PORT GOT STUCK HALFWAY THROUGH THE SHAFT OF THE NEEDLE. THIS RESULTED IN NOT BEING ABLE TO USE THE SAFETY MECHANISM, WHICH MEANS THERE WAS A POTENTIAL FOR THE TEAM MEMBER NEEDLE STICK AND ALSO PATIENT DISCOMFORT DUE TO DIFFICULT DE-ACCESSING THE PORT.

  Patient problems: Discomfort

  MAUDE report 18190472 ↗
• MalfunctionJun 20, 2023Defective Component; Detachment of Device or Device Component; Defective Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED INSTABILITY COMPARED TO THE EZ-HUBER AND TOO LOOSE ROTATION OF THE NEEDLE IN THE PLATE. THUS, THERE IS A RISK OF POSSIBLE DISLOCATION. NO OTHER INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17163876 ↗
• MalfunctionMay 1, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY THE CUSTOMER, "PORT ACCESSED BY HOMECARE ON 3/27/23, BARD POWERLOC NEEDLE, ADMITTED FOR CHEMO ON 3/28/23. METROTREXATE INFUSING 48 HOURS WITH NO ISSUES THROUGH THIS PORT NEEDLE. 3/29/23 1540 RN NOTICED HOLE IN PORT LINE TUBING NEAR BLUE CONNECTION PIECE, PORT DE-ACCESSED. BLOOD CULTURES DRAWN 3/29 PENDING."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16844166 ↗
• MalfunctionMay 1, 2023Break; Break

  IT WAS REPORTED BY THE CUSTOMER THAT, "PORT ACCESSED WITH NEEDLE 1¿ BARD POWERLOC MAX 20G ON (B)(6) 2023 1911 BY DCH. MULTIPLE IVS INFUSING THROUGH PORT NEEDLE. ON (B)(6) 2023, PATIENT WITH IV WITH BICARB INFUSING VIA PORT, AT 12:20 RN WENT TO DRAW LABS (48 HR METROTREXATE), RN NOTED LINE LEAKING, ATTEMPTED TO DRAW BLOOD CULTURES, BUT ONLY AIR RETURNED, BLOOD DRIPPING FROM LINE, PORT DE-ACCESSED. PORT TUBING TOTALLY DISCONNECTED FROM BLUE CONNECTION PIECE. BLOOD CULTURES DRAWN AND NEGATIVE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16843769 ↗
• MalfunctionMay 1, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY THE CUSTOMER THAT "PORT ACCESSED BY HOMECARE ON (B)(6) 2023, ADMITTED ON (B)(6) , PATIENT HAD IVF WITH BICARB INFUSING INTO HUBER NEEDLE. ON (B)(6) 23 1400 RN NOTICED HUBER NEEDLE TUBING LINE BROKEN, NOTICED BLOOD IN TUBING, AND RED AND CLEAR FLUID IN VALGUARD; NEEDLE DE-ACCESSED FROM PORT; HOLE IS NOTED IN TUBING RIGHT BEFORE CONNECTING TO THE LUER BLUE CONNECTION PIECE. BLOOD CULTURES DRAWN ON (B)(6) 10AM NEGATIVE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16843675 ↗
• MalfunctionApr 21, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY THE CUSTOMER THE PATIENT ACCESSED WITH BARD POWERLOC MAX AT THE HOSPITAL. PORT WAS ACCESSED WITH THIS NEEDLE ON 2/15/23 WITH MULTIPLE IVS/CHEMO INFUSING THROUGH IT UNTIL (B)(6) 23. AT -115AM RN NOTICED PATIENT LINE WITH HOLE AND BLEEDING. HOLE IS IN THE PORT NEEDLE TUBING RIGHT BEFORE IT CONNECTS TO THE LUER BLUE CONNECTION PORT. BLOOD CULTURES WERE DRAWN AND NEGATIVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16792403 ↗
• MalfunctionMay 26, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED "HUBER NEEDLE LUER LOCK HUB IS CRACKING. IT APPEARS WHEN THE ADAPTER IS TIGHTENED DOWN IT CRACKS THE SECOND HUB PORT." NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14519969 ↗
• MalfunctionMar 10, 2022Detachment of Device or Device Component; Activation Problem; Detachment of Device or Device Component; Activation Problem

  IT WAS REPORTED BY HEALTHCARE PROFESSIONAL "EVENT HAPPENED WHEN A NURSE WAS DEACCESSING A PORT TODAY. SHE WAS HOLDING IT PROPERLY AND WENT TO PULL THE NEEDLE BACK AND IT SNAPPED OFF. NO INJURY TO STAFF OR PATIENT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13721633 ↗
• MalfunctionDec 8, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED A BREAK AND SLIGHT BEND IN POWERLOC IN A COMPLEX CARE PATIENT. IT WAS STATED THIS PATIENT WAS RUNNING MAINTENANCE FLUID AND IS NOT MOBILE. ADDITIONAL INFORMATION RECEIVED: IT WAS REPORTED "NO HARM NOTED TO PATIENT, MAINTENANCE FLUID LEAKAGE, ALTHOUGH THE PATIENT DID REQUIRE A NEW PORT INSERTION WITH NO TIME FOR NUMBING CREAM AND RISK OF INFECTION STILL UNKNOWN." ADDITIONAL INFORMATION RECEIVED: PLEASE DESCRIBE WHEN THIS INCIDENCE OCCURRED IN THE WORKFLOW PROCESS? RN IN TO DRAW BLOOD ON HEPLOCKED PORT. WHEN FLUSHING NOTICED IT WAS LEAKING. PLEASE DESCRIBE THE AREA OF BREAKAGE? BREAK WAS COMPLETE - AT JUNCTION ON PORT BETWEEN TUBING AND HARD END WAS THERE DRUG IN LINE? NO, IT WAS HEPLOCKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12962620 ↗
• MalfunctionSep 28, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED A BREAK AT THE TUBING OF THE PORT ON A POWER PORT. THE PATIENT WAS NOT HARMED, HOWEVER THERE WAS A LOT OF BLOOD BACKING UP AND LEAKED ON THE BED. WE ARE MONITORING FOR CENTRAL LINE INFECTION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 12542531 ↗
• MalfunctionAug 26, 2021Restricted Flow rate; Restricted Flow rate

  IT WAS REPORTED THE CT POWER INJECTORS PRESSURING OUT. WHAT THEY¿RE BEING TREATED FOR: CHOLANGIOCARCINOMA OF THE LIVER, NO PT. HARM. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12370838 ↗
• MalfunctionAug 25, 2021Restricted Flow rate; Restricted Flow rate

  IT WAS REPORTED CT POWER INJECTORS PRESSURING OUT. WHAT THEY¿RE BEING TREATED FOR: PANCREATIC ADENOCARCINOMA, NO PT. HARM. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12367011 ↗
• MalfunctionNov 5, 2020Fluid/Blood Leak

  MATERIAL #:0142010 BATCH #: ASERF105. IT WAS REPORTED "WHEN NEEDLE WAS PRIMED HOLE WAS DISCOVERED AND SPRAYED OUT FLUID OUTSIDE OF CANNULA."

  Patient problems: No Patient Involvement

  MAUDE report 10796325 ↗