Port Access Needle 0682034Recalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 00801741048043), received between Nov 7, 2018 and Jan 20, 2026 — classified as 31 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (13 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 31 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 20, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT DURING ADMINISTRATION OF DRUG AND FLUID THE NURSE NOTICED MINOR LEAKAGE IN THE DEVICE BEFORE THE END OF THE TUBE OF THE Y CONNECTION. NO HARM TO PATIENTS. PATIENT'S SHIRT WAS A BIT WET. ADDITIONAL INFORMATION PROVIDED: LEAKAGE WAS DRUG & FLUID. IN ORDER TO VERIFY THE EXACT PLACE ON THE TUBE THEY WITHDRAW BLOOD FROM IT AND COULD NOTICE THE EXACT PLACE ON THE TUBE. A SPECIFIC NUMBER OF AFFECTED DEVICES OR PATIENTS WAS NOT PROVIDED BY THE COMPLAINANT.

  Patient problems: Insufficient Information

  MAUDE report 24120713 ↗
• MalfunctionJan 20, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT DURING ADMINISTRATION OF DRUG AND FLUID THE NURSE NOTICED MINOR LEAKAGE IN THE DEVICE BEFORE THE END OF THE TUBE OF THE Y CONNECTION. NO HARM TO PATIENTS. PATIENT'S SHIRT WAS A BIT WET. ADDITIONAL INFORMATION PROVIDED: LEAKAGE WAS DRUG & FLUID. IN ORDER TO VERIFY THE EXACT PLACE ON THE TUBE THEY WITHDRAW BLOOD FROM IT AND COULD NOTICE THE EXACT PLACE ON THE TUBE. A SPECIFIC NUMBER OF AFFECTED DEVICES OR PATIENTS WAS NOT PROVIDED BY THE COMPLAINANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24119599 ↗
• MalfunctionFeb 25, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THE MINI LOCK SAFETY INFUSION SET WAS USED TO ACCESS THE PORTS, THE NEEDLE WAS PLACED AND TRIED TO PULL SALINE THROUGH BUT INSTEAD OF THE SALINE STAYING IN THE DEVICE IT LEAKED DOWN THE PATIENT'S CHEST. THE NEEDLE WAS REMOVED AND REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21458747 ↗
• MalfunctionFeb 19, 2025Improper or Incorrect Procedure or Method; Detachment of Device or Device Component; Improper or Incorrect Procedure or Method; Detachment of Device or Device Component

  IT WAS REPORTED VIA POST MARKET SURVEY THAT CLINICIAN ENCOUNTERED MULTIPLE INSERTION ATTEMPTS WHILE USING THE BD MINILOC¿ HUBER NEEDLE SET (19GA × 0.75 INCHES / 19 MM) WITHOUT Y-SITE INSERTED THROUGH SEPTUM OF SURGICALLY IMPLANTED PORT FOR ADMINISTRATION OF FLUIDS, ADMINISTRATION OF MEDICATIONS / DRUGS, AND BLOOD SAMPLING. INITIALLY NO BACKFLOW WAS NOTED AND THE PORTACATH AREA GOT SWOLLEN AFTER INJECTING 10 MLS OF SALINE. NO OTHER INFORMATION WAS PROVIDED. A SPECIFIC NUMBER OF AFFECTED DEVICES OR PATIENTS WAS NOT PROVIDED BY THE COMPLAINANT.

  Patient problems: Swelling/ Edema

  MAUDE report 21407712 ↗
• MalfunctionFeb 19, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT CLINICIAN ENCOUNTERED LEAKAGE WHILE USING THE BD MINILOC¿ HUBER NEEDLE SET (19GA × 1.5 INCHES / 38 MM) WITHOUT Y-SITE INSERTED THROUGH SEPTUM OF SURGICALLY IMPLANTED PORT FOR ADMINISTRATION OF FLUIDS. NO OTHER INFORMATION WAS PROVIDED AND NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21407707 ↗
• MalfunctionApr 19, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THE CUSTOMER IS EXPERIENCING LEAKING Y SITES. NO OTHER INFORMATION WAS PROVIDED. THE EXACT QUANTITY OF LEAKING Y-SITES WAS NOT PROVIDED TO BD VASCULAR ACCESS FIELD ASSURANCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16773507 ↗
• MalfunctionMar 17, 2023Fluid/Blood Leak; Fluid/Blood Leak

  PER MEDWATCH RECEIVED: "PT WENT TO BATHROOM AT HOME, REALIZED TUBING HAD BROKEN. HER SHIRT WAS WET WITH CHEMO. THEN SHE CALLED THE AFTER-HOURS NURSE LINE AND CAME TO THE 24 HR CLINIC. SHOWERED, ASSESSED BY PROVIDER, SKIN AROUND PORT RED."

  Patient problems: Chemical Exposure; Skin Inflammation/ Irritation

  MAUDE report 16566585 ↗
• MalfunctionMar 8, 2023Misassembled; Improper or Incorrect Procedure or Method; Misassembled; Improper or Incorrect Procedure or Method

  CUSTOMER REPORTS THAT THESE NEEDLES "VERY DIFFICULT TO REMOVE SAFELY WITHOUT ENGAGING SAFETY." CUSTOMER HAS BEEN USING THE SAFESTEP HUBER NEEDLES PREVIOUSLY, IS ASKING IF THERE IS A DIFFERENCE BETWEEN THE TWO DEVICES WHEN REMOVING FROM THE IVAD THAT COULD BE CONTRIBUTING TO THESE CHALLENGES. CUSTOMER STATES THIS IS NOT CAUSING UNEXPECTED OR PROLONGED CARE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16503328 ↗
• MalfunctionMar 8, 2023Defective Component; Defective Component

  THE CUSTOMER REPORTS THAT THE CLAMPS "DO NOT CLAMP WELL." THE CUSTOMER HAS BEEN USING THE SAFESTEP HUBER NEEDLES PREVIOUSLY, IS ASKING IF THERE IS A DIFFERENCE BETWEEN THE TWO DEVICES WHEN REMOVING FROM THE IVAD THAT COULD BE CONTRIBUTING TO THESE CHALLENGES. CUSTOMER STATES THIS IS NOT CAUSING UNEXPECTED OR PROLONGED CARE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16503280 ↗
• MalfunctionSep 29, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED WE HAVE HAD A COMPLAINT FROM A PATIENT REGARDING THE PORT SITE LEAKING. THE STAFF IS CONCERNED ABOUT THE POSSIBILITY OF LEAKAGE WITH THE PUMPS WHILE THE PATIENTS ARE AT HOME. ADD INFO REC'D 09/13/2022: EVENT INFORMATION: WHAT WAS THE TYPE OF CHEMO MEDICATION THAT LEAKED? ADRIAMYCIN. WAS THE HEALTHCARE PROVIDER EXPOSED TO THE MEDICATION AFTER IT WAS IN CONTACT WITH THE PATIENT? NO. WAS THERE EXPOSURE TO BLOOD OR OTHER MEDICATION? NO. PATIENT INFORMATION: WAS THERE ANY PATIENT HARM REPORTED? IF YES, PLEASE DESCRIBE THE HARM, HOW IT WAS TREATED AND THE OUTCOME. NO, PATIENT CAME TO THE FACILITY AND HUBER NEEDLE AND TUBING REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15506336 ↗
• MalfunctionJul 29, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED BY HEALTHCARE PROFESSIONAL "WE HAD A MINILOC PORT ACCESS KIT FROM BARD USED ON THURSDAY LAST WEEK AND ONE SIDE OF THE "Y" WAS NOT ACTUALLY CONNECTED." NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15136078 ↗
• MalfunctionJul 15, 2022Fluid/Blood Leak; Detachment of Device or Device Component; Fluid/Blood Leak; Detachment of Device or Device Component

  IT WAS REPORTED BY THE CUSTOMER "PATIENT PRESENTED TO CLINIC WITH NEEDLE INTACT/PORT ACCESSED. DRESSING INTACT, ABLE TO FLUSH PORT, BLOOD RETURN OBTAINED. WHILE AT HOME, PATIENT STATED THAT HE NOTICED THAT THE IV TUBING HAD BECOME COMPLETELY DISLODGED FROM THE PRIMARY HUB CONNECTION SITE ON THE INFUSION SET."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15033873 ↗
• MalfunctionOct 13, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT "(MINILOC) LEAKED AFTER TIGHTENING. THEY ARE CURRENTLY USING A MEDLIN KIT WITH TWO POSITIVE PRESSURE NEEDLES VALVES, THEY ARE IN PROCESS OF PUTTING T." ADDITIONAL INFORMATION RCVD 09/27/2021: "I DO NOT HAVE SPECIFIC LOT NUMBERS FOR THESE INCIDENTS, BUT THE LEAKAGE HAS HAPPENED WITH ALMOST EVERY NEEDLE (AND CONTINUES TO) SINCE WE STARTED USING THE PRODUCT APPROXIMATELY ONE MONTH AGO. THE CAP ON THE LOWER PORT IS LOOSE WHICH ALLOWS THE BLOOD TO LEAK OUT. WE USE APPROXIMATELY 30-50 PORT NEEDLES PER DAY. "

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12627894 ↗
• MalfunctionMar 12, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED NOTED TO BE LEAKING FROM UPPER Y- SITE OF BARD MINILOC SAFETY INFUSION SET 20G 3/4 INCH. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11474909 ↗
• MalfunctionJul 10, 2020Crack; Crack

  IT WAS REPORTED THAT THE MINILOC NEEDLE LEAKED AT THE Y-SITE DURING CHEMOTHERAPY INFUSION. IT WAS STATED THAT THIS HAPPENED THE SAME DAY IT WAS PLACED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10257634 ↗
• MalfunctionMay 14, 2020Crack; Crack

  IT WAS REPORTED THE PATIENT WAS ACCESSED ON (B)(6) 2020 AND SENT HOME WITH PORT ACCESSED (HEPARIN LOCKED PER INSTITUTION POLICY). UPON CHECKING PORT NEEDLE A CRACK WAS NOTED ON (B)(6) 2020.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10055619 ↗
• MalfunctionApr 29, 2020Crack; Crack

  IT WAS REPORTED THE MINILOC LEAKED AT THE Y-SITE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10009113 ↗
• MalfunctionApr 2, 2020Crack; Crack

  IT WAS REPORTED "WE HAVE BEEN NOTING CRACKING NEAR THE Y CONNECTION, THE CRACKING HAS BEEN NOTED ON RETURN WHEN PATIENTS ARE HAVING THEIR PORTS ACCESSED FOR SEVERAL DAYS DUE TO TREATMENT." IT WAS STATED THIS HAPPENED WITH THREE PATIENTS. THIS REPORT ADDRESSES THE SECOND PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9916047 ↗
• MalfunctionApr 2, 2020Crack; Crack

  IT WAS REPORTED THE NEEDLE CRACKED NEAR THE Y CONNECTION. IT WAS STATED THE PORT HAD BEEN ACCESSED FOR SEVERAL DAYS DUE TO TREATMENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9916044 ↗
• MalfunctionApr 2, 2020Crack; Crack

  IT WAS REPORTED "WE HAVE BEEN NOTING CRACKING NEAR THE Y CONNECTION, THE CRACKING HAS BEEN NOTED ON RETURN WHEN PATIENTS ARE HAVING THEIR PORTS ACCESSED FOR SEVERAL DAYS DUE TO TREATMENT." IT WAS STATED THIS HAPPENED WITH THREE PATIENTS. THIS REPORT ADDRESSES THE FIRST PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9915993 ↗
• MalfunctionApr 2, 2020Crack; Crack

  IT WAS REPORTED "WE HAVE BEEN NOTING CRACKING NEAR THE Y CONNECTION, THE CRACKING HAS BEEN NOTED ON RETURN WHEN PATIENTS ARE HAVING THEIR PORTS ACCESSED FOR SEVERAL DAYS DUE TO TREATMENT." IT WAS STATED THIS HAPPENED WITH THREE PATIENTS. THIS REPORT ADDRESSES THE THIRD PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9915991 ↗
• MalfunctionMar 18, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED "THAT 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."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9848942 ↗
• MalfunctionDec 23, 2019Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED VIA MS&S CUSTOMER REPORTS ONCOLOGY PATIENT RECEIVING CHEMOTHERAPY WAS ACCESS IN ONCOLOGY WITH CHEMOTHERAPY STARTED AND WAS THEN DISCHARGED TO HOME TO COMPLETE THE 4-6 HOUR INFUSION WHEN "AFTER A WHILE AT HOME THE TUBING SEPARATED FROM THE CASING RESULTING IN BLEEDING AND CHEMOTHERAPY IN THE HOME." CUSTOMER STATES MINILOC WAS COVERED WITH AN OCCLUSIVE DRESSING WHEN PATIENT WAS DISCHARGED TO HOME. (B)(6)2019 : NO PATIENT HARM REPORTED. (B)(6)2020 : ADDITIONAL INFORMATION REC'D VIA MEDWATCH: "A PT IN OUR ONCOLOGY DEPT. WAS RECEIVING CHEMOTHERAPY (5FU-FLUOROURACIL). THIS WAS PART OF A 48 HOUR LONG INFUSION. THE PT WAS RECEIVING THE COURSE OF HIS CHEMO AT HOME. THE ACCESS DEVICE-BARD MINILOC SAFETY INFUSION SET WAS USED. THE TUBING SEPARATED FROM THE HARD PLASTIC END (NOT BROKEN, BUT SLID OUT OF THE CASING). AS THIS WAS ACCESSING A CENTRAL LINE, THE PT LOST QUITE A BIT OF BLOOD AT HOME PRIOR TO BEING ABLE TO CLAMP OFF THE ACCESS DEVICE. FURTHERMORE, THIS RESULTED IN A SMALL QUANTITY BEING WASTED AS THE MEDICATION PUMP KEPT INFUSING."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9513336 ↗
• MalfunctionOct 15, 2019Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED VIA MEDWATCH " PT CALLED FROM BATHROOM AND STATES HIS "PORT CAME OUT". CAME IN TO ASSESS SAME AND NOTED THAT NIGHT PORT HAD PULLED PART AT Y-SITE BEFORE LUMENS. UNABLE TO CLAMP TUBING DUE TO SAME. RT PORT NEEDLE AND DRESSING STILL INTACT. PT AD JUST GOTTEN OUT OF SHOWER AT THIS TIME AND STATES HE IS UNAWARE OF HOW THIS HAPPENED AS HE DOES NOT REMEMBER PULLING ON SAME. PT LIED DOWN IN BED, DE-ACCESSED AND RE-ACCESS PORT WITHOUT INCIDENT. DR MADE AWARE OF INCIDENT AS WELL AS PICC TEAM. WILL CONTINUE TO MONITOR SAME."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9195150 ↗
• MalfunctionJul 3, 2019Crack; Leak/Splash

  IT WAS REPORTED THAT THE PROXIMAL ACCESS PORT CRACKED AND LEAKED FLUORICIL ON THE PATIENT. NO HARM TO PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8757459 ↗