Port Access Needle 0632010Recalls & reported problems
Bard Access Systems, Inc. · MiniLoc 20G x 1 inch · Class 2
All models of Port Access Needle (122)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This is a Bard MiniLoc port access needle, used to access implanted ports for IV fluids and medication. The 34 reports mostly describe the needle leaking fluid or blood at the connection point, along with some breakage, holes in the device packaging, and activation problems. No deaths were reported and 2 injuries were reported. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 33
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 00801741047541), received between Aug 23, 2018 and Sep 22, 2026 — classified as 2 injuries, 31 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (22 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.
Reports received per month
Most reported problems
Device problems
- Fluid/Blood Leak22
- Break4
- Activation Problem2
- Tear, Rip or Hole in Device Packaging2
- Component Missing1
- Detachment of Device or Device Component1
- Material Protrusion/Extrusion1
- Material Puncture/Hole1
Patient problems
- No Clinical Signs, Symptoms or Conditions28
- No Patient Involvement2
- Bacteremia1
- Fever1
- Insufficient Information1
- Needle Stick/Puncture1
- No Code Available1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 25 most recent of 33 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 22, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50858512 ↗MalfunctionSep 22, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50858510 ↗MalfunctionMay 11, 2026Fluid/Blood Leak
IT WAS REPORTED THE NEEDLE IS LEAKING (AT THE CONNECTION BETWEEN THE NEEDLE AND THE EXTENSION). THERE WAS NO DAMAGE TO THE PATIENT. LEAKING SALINE SOLUTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25143319 ↗MalfunctionMar 25, 2026Fluid/Blood Leak
IT WAS REPORTED THAT THERE WAS A LEAKING NEEDLE. THERE WAS NO HARM TO THE PATIENT'S HEALTH. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24687332 ↗MalfunctionMar 19, 2026Fluid/Blood Leak
IT WAS REPORTED LEAKING NEEDLE. THERE WAS NO DAMAGE TO THE PATIENT'S HEALTH.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24640162 ↗MalfunctionMar 19, 2026Fluid/Blood Leak
IT WAS REPORTED LEAKING NEEDLE. THERE WAS NO DAMAGE TO THE PATIENT'S HEALTH.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24640147 ↗MalfunctionMar 9, 2026Fluid/Blood Leak
IT WAS REPORTED LEAKING. THERE WAS NO DAMAGE TO PATIENT'S HEALTH. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24553988 ↗MalfunctionJan 20, 2026Activation Problem
IT WAS REPORTED SAFETY DEVICE DID NOT ACTIVATE CORRECTLY AFTER REMOVAL. THERE WAS NO DAMAGE TO THE PATIENT'S HEALTH.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24122222 ↗MalfunctionDec 29, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT DURING THE APPOINTMENT OF A PATIENT SCHEDULED FOR HERCEPTIN ADMINISTRATION, A COMPLICATION RELATED TO THE MATERIAL USED FOR CATHETER PUNCTURE WAS IDENTIFIED. AFTER PUNCTURING WITH AN ONCOKIT NEEDLE, FLUSHING WITH SALINE SOLUTION WAS PERFORMED, AT WHICH POINT A LEAKING OF SOLUTION WAS OBSERVED FROM THE UPPER PART OF THE NEEDLE TIP. THE PUNCTURE WAS STOPPED IMMEDIATELY, AND THE MATERIAL WAS DISCARDED. NO FURTHER INFORMATION PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23919278 ↗MalfunctionNov 11, 2025Fluid/Blood Leak; Detachment of Device or Device Component; Fluid/Blood Leak; Detachment of Device or Device Component
ADDITIONAL INFORMATION PROVIDED 11/10. MEDICATIONS INFUSED 10/22-10/25: BLINATUMOMAB.
Patient problems: Insufficient Information
MAUDE report 23527032 ↗MalfunctionOct 21, 2025Break; Break
IT WAS REPORTED PORT NEEDLE TUBING SEVERED (THE TUBING BONDED TO THE NEEDLE) WHILE IN USE. PATIENT WAS EXPOSED TO HD DRUG. NO FURTHER INFORMATION WAS PROVIDED. THE DEVICE WAS DISPOSED OF AT THE TIME OF THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23352706 ↗MalfunctionOct 21, 2025Break; Break
ADDITIONAL INFORMATION PROVIDED 11/17. MEDICATIONS USED (B)(6) 2025: ETOPOSIDE, IFOSFAMIDE, MESNA, DEXTROSE, SODIUM CHLORIDE, POTASSIUM, CHLORIDE, GRANISETRON.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23352145 ↗MalfunctionOct 21, 2025Break; Break
ADDITIONAL INFORMATION PROVIDED 11/17; MEDICATIONS USED (B)(6) 2025 -(B)(6) 2025: HYDROMORPHONE, KETOROLAC, HEPARIN LOCK (30 UNITS), KETAMINE, NALOXONE (DRIP), ONDANSETRON.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23352133 ↗MalfunctionOct 21, 2025Break; Break
ADDITIONAL INFORMATION PROVIDED 11/17. MEDICATIONS USED (B)(6) 2025: HYDROMORPHONE, KETOROLAC, MORPHINE, HEPARIN LOCK (30 UNITS), KETAMINE, NALOXONE (DRIP), ONDANSETRON.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23350780 ↗MalfunctionOct 15, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT PATIENT WITH A 46-HOUR INFUSION CONTACTS THE SERVICE REPORTING BLEEDING AT THE CATHETER PUNCTURE SITE. HE COMES TO THE SERVICE; THE PROFESSIONAL EXAMINES HIM AND NOTICES A SMALL AMOUNT OF BLEEDING AT THE SITE. THE PUNCTURE IS REMOVED. ACCORDING TO THE CLIENT, THE MEDICATION BEING ADMINISTERED WAS FAULDFLUOR/FLUORACILA. THE PATIENT RETURNED TO THE HEALTHCARE FACILITY AFTER NOTICING BLOOD IN THE CHEST AREA, BELOW THE PUNCTURE SITE, AS WELL AS BLOOD LEAKING FROM THE PUNCTURE HOLE. THE PATIENT HAD NO APPARENT INJURIES. AFTER IDENTIFYING THE PROBLEM, A NEW PUNCTURE WAS PERFORMED USING A MINILOC FROM A DIFFERENT BATCH.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23293473 ↗MalfunctionOct 15, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT LEAKAGE OF SOLUTION WAS OBSERVED AT THE TIME OF SALINE SOLUTION INJECTION. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23292552 ↗MalfunctionJul 16, 2025Component Missing; Component Missing
IT WAS REPORTED BY THE CUSTOMER THAT ON (B)(6) 2024, A NEEDLE WAS IDENTIFIED AS NOT COMING WITH THE PROTECTOR (COVER). THE PROBLEM WAS IDENTIFIED DURING PREPARATION AND DID NOT RESULT IN ANY HARM TO THE PATIENT. NO FURTHER INFORMATION PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22519520 ↗MalfunctionMay 9, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED, NEEDLE CROOKED AND DEVICE SEMI-TRACTED. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21994718 ↗MalfunctionJan 22, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT ON (B)(6) 2024, DURING THE PUNCTURE OF PATIENT BY THE NURSE WITH THE MINILOC 20 G X 25 MM, THE PROFESSIONAL NOTICED LEAKING PHYSIOLOGICAL SOLUTION IN THE REGION OF THE CATHETER AND NEEDLE CONNECTION. A NEW UNIT WAS USED, WITH NO NEW COMPLICATIONS RECORDED. NO PATIENT IMPACT, NO SURGICAL INTERVENTION, AND NO EXPOSURE TO BLOOD OR BODILY FLUID. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21211331 ↗InjuryNov 14, 2024Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED BY CUSTOMER THAT DURING THE CONTINUOUS ADMINISTRATION OF BLINATUMOMAB, THE TUBING IS CRACKING AT THE DISTAL SECTION OF PORT TUBING JUST ABOVE THE Q-SITE. ADDITIONAL INFORMATION RECEIVED 10/23/2024: PATIENT WAS RECEIVING BLINATUMOMAB IN THE HOSPITAL SETTING WHEN HIS PORT LINE CRACKED. WITHIN 24 OF THE PORT CRACKING, THE PATIENT SPIKED A FEVER AND GREW POSITIVE BLOOD CULTURES RESULTING IN A CLABSI. PERIPHERAL IV PLACED FOR ANTIBIOTIC ADMINISTRATION. CONTINUOUS BLINATUMOMAB STOPPED FOR 3 DAYS. PICC LINE PLACED TO INFUSE ANTIBIOTIC THERAPY WITHOUT FURTHER INTERRUPTIONS OF CONTINUOUS BLINATUMOMAB. THE SAME PATIENT WAS RECEIVING BLINATUMOMAB IN THE HOSPITAL SETTING WHEN HIS PORT LINE CRACKED AGAIN. WITHIN 24 OF THE PORT CRACKING, THE PATIENT SPIKED A FEVER AND GREW POSITIVE BLOOD CULTURES. OUR INFECTIOUS DISEASE TEAM IS REVIEWING THE CASE, BUT THIS WILL RESULT IN ANOTHER CLABSI FOR THIS PATIENT. IT WAS DETERMINED THAT HIS INDWELLING PORT NEEDED TO BE REMOVED UNDER SURGERY. HIS CONTINUOUS BLINATUMOMAB WAS STOPPED 1 DAY EARLY. THIS REPORT ADDRESSES THE FIRST CRACKED NEEDLE THAT STOPPED TREATMENT FOR 3 DAYS.
Patient problems: Bacteremia; Fever
MAUDE report 20691649 ↗MalfunctionSep 12, 2024Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED, "I BELIEVE IT'S A BROKEN NEEDLE." ADDITIONAL INFORMATION RECEIVED ON 08/30/2025: LEAKAGE IN THE YELLOW CONNECTION WITH THE NEEDLE, A TEST WAS PERFORMED. THE PATIENT WAS INVOLVED, BUT THERE WAS NO DAMAGE TO THE PATIENT. THERE WAS NO INVOLVEMENT OF MEDICAL INTERVENTION. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20201847 ↗MalfunctionJul 25, 2024Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED WHEN PUNCTURING THE CATHETER (PORT A CATH) AND SALINIZING WITH THE POSIFLUSH SYRINGE, THE NURSE NOTICES LEAKING BETWEEN THE PROBE AND THE CONNECTION.. THERE WAS NO HARM TO THE PATIENT. PATIENT IN GOOD GENERAL CONDITION. THE EXACT LOCATION OF THE LEAKING WAS BETWEEN THE PROBE CONNECTION AND THE PVC PIPE. A PHYSIOLOGICAL SOLUTION WAS BEING USED AT THE TIME OF THE INCIDENT AS THE PATIENT WAS BEING PUNCTURED FOR CHEMOTHERAPY TREATMENT. THERE WAS NO NEED FOR MEDICAL INTERVENTION. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19826278 ↗InjuryApr 19, 2023Activation Problem; Activation Problem
IT WAS REPORTED DIFFICULTY ACTIVATING THE SAFETY AS WELL AS ACCESSING PATIENT. RESULTED IN NEEDLE STICK. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: Needle Stick/Puncture
MAUDE report 16769348 ↗MalfunctionSep 30, 2022Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THE NEEDLE LEAKS IN THE PART BELOW THE PROTECTIVE BUTTERFLY, CAUSING THE MEDICATION (CHEMOTHERAPEUTIC) TO COME INTO CONTACT WITH THE PATIENT'S SKIN. THERE WAS NO SERIOUS INJURY TO THE PATIENT'S HEALTH, AS THE PROBLEM WAS DETECTED IN TIME. IT WAS REPORTED THIS OCCURRED WITH FOUR DEVICES. THIS REPORT ADDRESSES THE FOURTH DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15514945 ↗MalfunctionSep 29, 2022Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THE NEEDLE LEAKS IN THE PART BELOW THE PROTECTIVE BUTTERFLY, CAUSING THE MEDICATION (CHEMOTHERAPEUTIC) TO COME INTO CONTACT WITH THE PATIENT'S SKIN. THERE WAS NO SERIOUS INJURY TO THE PATIENT'S HEALTH, AS THE PROBLEM WAS DETECTED IN TIME. IT WAS REPORTED THIS OCCURRED WITH FOUR DEVICES. THIS REPORT ADDRESSES THE THIRD DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15505582 ↗
Other Set, administration, intravascular devices
- Autosoft XC 1001680Unomedical A/S · Set, Administration, Intravascular1 death16,105 reports
- Autosoft90™ 1002817Unomedical A/S · Set, Administration, Intravascular1 recall11,907 reports
- Minimed™ Quick-set™ MMT-399AUnomedical A/S · Set, Administration, Intravascular9 deaths8,669 reports
- Medtronic Extended MMT-431AUnomedical A/S · Set, Administration, Intravascular3 deaths8,574 reports
- MiniMed™ Mio™ Advance MMT-242AUnomedical A/S · Set, Administration, Intravascular15 deaths8,164 reports
- CADD 21-7302-24Icu Medical, Inc. · Set, administration, intravascular4 recalls1 death4,657 reports
- Autosoft XC 1001681Unomedical A/S · Set, Administration, Intravascular1 death4,216 reports
- Minimed™ Quick-set™ MMT-397AUnomedical A/S · Set, Administration, Intravascular19 deaths4,134 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page