Port Access Needle 012001Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00801741065552), received between May 31, 2019 and Jul 21, 2022 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Activation Problem” (2 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 21, 2022Activation Problem; Activation Problem

  IT WAS REPORTED THAT THE NEEDLE CAN¿T RETRACTED. PATIENT STATUS/ INTERVENTION: CHANGE NEW NEEDLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15075640 ↗
• MalfunctionJul 20, 2022Activation Problem; Activation Problem

  IT WAS REPORTED THAT THE NEEDLE CANT RETRACTED. PATIENT STATUS/ INTERVENTION: CHANGE NEW NEEDLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15068043 ↗
• MalfunctionFeb 19, 2020Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  IT WAS REPORTED THAT THE PATIENT BROUGHT CHEMOTHERAPY DRUG HOME FOR CHEMOTHERAPY TREATMENT, THE DRUG WAS FOUND LEAK FROM THE CONNECTION SITE BETWEEN DEVICE AND CONNECTOR. THEN BACK TO HOSPITAL AND HANDLE WITH CHEMOTHERAPY DRUG LEAK SOP PROCESS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9729790 ↗
• InjuryNov 25, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED, "I HAVE BEEN USING THE HUBER PLUS NEEDLE AND THE PAST FEW MONTHS I¿M BLISTERING, WITH SOME CLEAR FLUID LEAKING, RIGHT WHERE THE NEEDLE GOES INTO MY PORT. I TOOK A 2 MONTH BREAK FROM BEING ACCESSED AND MOSTLY CLEARED BUT NOW IT¿S HAPPENING ALL OVER AGAIN. WHAT EXACTLY ARE YOUR NEEDLES MADE OUT OF? I WANT TO GET ALLERGY TESTED TO SEE IF I¿M ALLERGIC BUT CAN¿T FIND WHAT TO TEST FOR." (B)(6) 2019: ADDITIONAL INFORMATION FROM PATIENT REPORTED THE PATIENT BLISTER RIGHT WHERE THE NEEDLE GOES. A LITTLE BIT OF THE FLUID WOULD COME OUT OF THE BLISTER AND/OR BLEEDING. THE SITE WAS TENDER, ITCHY OFF AND ON WITH REDNESS & SWELLING. IT WAS STATED AN INFECTION WAS NOT CONFIRMED BUT WAS PRESCRIBED AN ANTIBIOTIC FLUCONAZOLE 100 MG FOR 5 DAYS ON (B)(6).

  Patient problems: Local Reaction

  MAUDE report 9370928 ↗
• MalfunctionJul 23, 2019Leak/Splash

  IT WAS REPORTED THAT THERE WAS DRUG(BLOOD) LEAKAGE FROM THE CONNECTOR. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8818616 ↗
• MalfunctionJun 6, 2019Fluid/Blood Leak

  IT WAS REPORTED THE PORT NEEDLE WAS CONNECTED TO NACL, AFTER ABOUT 1 HOUR, THE NURSE NOTICED THAT THE INFUSION HAS COMPLETELY RUN OUT. IT WAS STATED IT LEAKED AND DRIPPED AT THE CONNECTION BETWEEN LUER AND INFUSION LINE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8675663 ↗
• MalfunctionMay 31, 2019Leak/Splash

  IT WAS REPORTED, " IN THE ISOLATED PATIENT, THE PORT NEEDLE WAS CONNECTED TO NACL. AFTERWARD, THE NURSE LEFT THE ROOM. AFTER ABOUT 1 HOUR, THE NURSE NOTICED THAT THE INFUSION HAS COMPLETELY RUN OUT. IT DRIPPED AT THE CONNECTION BETWEEN LUER AND INFUSION LINE."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8659899 ↗