Port Access Needle 0682010Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00801741048029), received between Mar 18, 2020 and Feb 25, 2025 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (7 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 25, 2025Activation Problem; Activation Problem

  IT WAS REPORTED BY CUSTOMER WE RECENTLY HAD A PATIENT THAT HAD A MINILOC MALFUNCTION. THE SAFETY FAILED TO ENGAGE. PER THE NURSE THE LOCK WOULD CLICK SHUT AND THEN REOPEN. THIS HAPPENED 3 TIMES. NO PATIENT HARM, INJURY OR NEGATIVE OUTCOME OCCURRED AS A RESULT OF THIS EVENT. THIS REPORT ADDRESSES ALL 3 OCCURRENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21458763 ↗
• MalfunctionDec 6, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT WHEN PRIMING THE MINILOC SAFETY NEEDLE THERE IS LEAKAGE. LEAKAGE FROM THE NEEDLE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18274975 ↗
• MalfunctionFeb 24, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED, MINILOC TUBING HAS 2 PORTS. THE PORT CLOSEST TO THE NEEDLE HAS A HARD CAP. WHILE THE PATIENT WAS IN THE PHYSICIAN¿S OFFICE, THE HARD CAP WAS OBSERVED OFF AND BLOOD WAS COMING OUT OF IT ONTO THE PATIENT'S SHIRT. THE PORT NEEDLE WAS REMOVED WITHOUT KNOWN HARM TO PATIENT. IT IS UNCLEAR HOW THE SCREW CAP CAME OFF. MINILOC WAS INTENDED TO BE USED FOR INFUSION THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16440784 ↗
• MalfunctionFeb 7, 2023Disconnection; Fluid/Blood Leak

  EARLY 70¿S FEMALE WITH HISTORY OF OVARIAN CANCER. PROCEDURE: INFUSION THERAPY. MINILOC TUBING HAS 2 PORTS. THE PORT CLOSEST TO THE NEEDLE HAS A HARD CAP. WHILE THE PATIENT WAS IN THE PHYSICIAN¿S OFFICE, THE HARD CAP WAS OBSERVED OFF AND BLOOD WAS COMING OUT OF IT ONTO THE PATIENT'S SHIRT. THE PORT NEEDLE WAS REMOVED WITHOUT KNOWN HARM TO PATIENT. IT IS UNCLEAR HOW THE SCREW CAP CAME OFF.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 16310844 ↗
• MalfunctionNov 6, 2020Crack; Radiation Leak

  IT WAS REPORTED "ONE OF MY OMC SITES HAD A PATIENT WITH A CRACKED HUB. IT RESULTED IN CHEMOTHERAPY LEAKING AND THE PATIENT HAD TO GO TO THE ER. LOT #ASERF029. THIS IS CONTINUING TO BE AN ISSUE RESULTING IN UNNECESSARY PATIENT TRIPS TO THE ER AND IS A PATIENT SAFETY ISSUE AS OUR PATIENTS ARE BEING EXPOSED TO CHEMOTHERAPY." ADD INFO RCVD 10/14/2020: WHAT TYPE OF CATHETER SECUREMENT WAS UTILIZED: TEGADERM AND SILK TAPE WAS THERE PATIENT HARM REPORTED?: PATIENT WAS EXPOSED TO A HAZARDOUS MEDICATION AND HAD TO GO TO ER.

  Patient problems: Chemical Exposure

  MAUDE report 10802448 ↗
• MalfunctionOct 12, 2020Crack; Fluid/Blood Leak

  IT WAS REPORTED A PATIENT CAME TO THE UNIT WITH A CRACKED Y-SITE ON A 1¿ HUBER NEEDLE WHICH CAUSED LEAKING. ADDITIONAL INFO. RECEIVED 09/23/2020: "WHAT TYPE OF CATHETER SECUREMENT WAS UTILIZED? TEGADERM". "WAS THERE PATIENT HARM REPORTED?: YES, CHEMOTHERAPY LEAKED ONTO PATIENT¿S SKIN".

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10663054 ↗
• MalfunctionSep 17, 2020Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  IT WAS REPORTED "WE HAD A PATIENT COME TO THE UNIT WITH A CRACKED Y-SITE. WE HOOKED UP HER 5-FU PUMP AROUND 4:15PM YESTERDAY AND SHE SAID IT WAS FINE UNTIL ~12:30 SHE HAD NOTICED IT WAS LEAKING BLOOD. THE LINE WAS FLUSHED THE AND THAT¿S WHEN IT WAS NOTED THAT THE HUB CLOSEST TO THE PATIENT WAS CRACKED AND LEAKING.¿

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10549679 ↗
• MalfunctionAug 12, 2020Crack; Crack

  IT WAS REPORTED "THE PATIENT CALLED THE UNIT STATING THAT HIS PUMP WAS LEAKING, UPON ARRIVAL THE CLOSEST HUB TO THE PATIENT WAS CRUSTED WITH 5FU. WE REMOVED THE NEEDLE AND RE ACCESSED THE PATIENT. HE CAME BACK TO THE UNIT 24 HOURS LATER TO HAVE HIS PUMP DISCONNECTED" TM REPORTED "CRACKED Y-SITE AT" HOSPITAL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10395497 ↗
• MalfunctionApr 28, 2020Crack; Crack

  IT WAS REPORTED THAT THE MINILOC WAS NOTED TO BE LEAKING AT THE Y-SITE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10005794 ↗
• MalfunctionApr 23, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED "PATIENT WAS REPORTED APPROXIMATELY 2 WEEKS AGO PATIENT WAS ACCESSED AND WENT HOME ON A 5 FU PUMP. THE PATIENT CALLED THE PHYSICIAN SHORTLY AFTER BEING ACCESSED TO REPORT THAT THERE WAS LEAKING."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9991160 ↗
• MalfunctionApr 23, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED "PATIENT WAS ACCESSED ON (B)(6). THERE WAS NO REPORTED LEAKING AT TIME OF ACCESS. PATIENT WAS CONNECTED TO A 5 FU PUMP FOR AT HOME INFUSION. PATIENT CAME BACK INTO THE INFUSION CENTER ON (B)(6), AND WAS NOT AWARE OF ANY LEAKING. NURSING DISCOVERED THAT THERE WAS A LEAK (CRACKING IN THE Y-SITE) WHEN THEY SAW WHITE RESIDUE FROM 5FU LEAKING ON THE PATIENT."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9991152 ↗
• MalfunctionApr 23, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED "A PATIENT WHO HAD BEEN ACCESSED SEVERAL DAYS BEFORE AND WAS CONNECTED TO A 5FU PUMP HAD LEAKING AT THE Y-SITE WHEN THE PATIENT RETURNED TO THE ONCOLOGY INFUSION AREA TO BE DE-ACCESSED." 04/13/2020: ADDITIONAL INFORMATION RECEIVED STATED, " PATIENT ARRIVED ON (B)(6) FOR AN UNPLANNED VISIT BECAUSE HUB OF HUBER NEEDLE WAS CRACKED AND CHEMOTHERAPY WAS LEAKING ONTO PATIENT. PATIENT DROVE 1 HOUR BACK TO HOSPITAL TO HAVE SITE EVALUATED, PORT NEEDLE WAS REMOVED, PORT WAS REACCESSED WITH A NEW HUBER NEEDLE AND A NEW 5FU PUMP WAS GIVEN TO PATIENT TO COME THE FOLLOWING DAY FOR THEIR SCHEDULED PUMP DISCONNECT."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9990899 ↗
• MalfunctionMar 18, 2020Crack; Crack

  IT WAS REPORTED "THE PORT NEEDLES CHANGED. I WAS ABLE TO OBTAIN A NEW AND OLD PORT NEEDLE. THE DIFFERENCE IS THE OLD PORT NEEDLES HAD BLUE CAPS AND WHITE CLIPS. THEY WERE MADE IN MEXICO. THE NEW NEEDLES HAVE WHITE CAPS AND CLEAR CLIPS AND ARE MADE IN CHINA. NOW THAT THE NEWER NEEDLES ARE MAKING THERE WAYS INTO ALL OF THE AHS INFUSION CENTERS WE ARE SEEING MORE AND MORE CRACKS." 2/28/2020- ADDITIONAL INFORMATION RECEIVED STATED, "PATIENT WAS ACCESSED ON (B)(6) AND WAS INFUSED WITH NO LEAKING. PATIENT WENT HOME ON A 5FU PUMP. WHEN THE PATIENT WOKE UP THE NEXT MORNING, THE INFUSION HAD LEAKED ALL OVER THE PATIENT AND ALSO THE BED. PATIENT CALLED PHYSICIAN AND WAS ADVISED TO GO TO THE ER IN WHICH TO BE DE-ACCESSED. UPON INVESTIGATION OF THE PORT NEEDLE THERE WAS A FINE CRACK ON THE Y-SITE CLOSEST TO THE PATIENT. THIS IS COMMONLY NOT THE SITE THAT IS ACCESSED, BUT AN ADDITIONAL ORANGE CAP IS PLACED OVER THIS PORT THAT WAS NOT ACCESSED."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9849026 ↗