Port Access Needle 0672034Recalls & reported problems
Bard Access Systems, Inc. · PowerLoc 20G x 0.75 inch with y-site · 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 PowerLoc port access needle, a set used to put IV medicine into a patient's implanted port. The 65 reports mostly describe leaking of fluid or blood, cracks in the needle, and parts coming apart — including a rubber valve blowing out of the end cap during a CT scan and Y-sites detaching from chemo tubing. No deaths and no injuries are reported, though some patients had chemo interrupted and delayed. No recalls name this device, and no reports were filed in the past 12 months.
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
- 66
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 66 adverse event reports that list this exact device (DI 00801741047947), received between Jun 7, 2019 and Sep 23, 2026 — classified as 66 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (34 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 Leak34
- Crack24
- Activation Problem6
- Break3
- Detachment of Device or Device Component2
- Component Missing1
Patient problems
- No Clinical Signs, Symptoms or Conditions34
- No Consequences Or Impact To Patient14
- Insufficient Information7
- Chemical Exposure5
- No Known Impact Or Consequence To Patient4
- Needle Stick/Puncture2
- No Patient Involvement2
- Exposure to Body Fluids1
Recent adverse event reports
The 25 most recent of 66 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 23, 2026Activation Problem
It was reported we had a needlestick with a reproducible faulty safety in the product. No further information was provided.
Patient problems: Needle Stick/Puncture
MAUDE report 50863225 ↗MalfunctionMay 9, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED, RUBBER VALVE BLEW OUT OF THE TOP OF THE END CAP. DURING PATIENTS CAT SCAN, RUBBER VALVE INSIDE END CAP OF SECOND INJECTION PORT SITE, BLEW OUT OF THE TOP OF THE END CAP FROM THE PRESSURE OF THE CAT SCAN CONTRAST INJECTION. PATIENT WAS SATURATED WITH CONTRAST DYE. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21995291 ↗MalfunctionJan 6, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT WHEN FLUSHING TO PREP THE NEEDLE FOR ACCESS, THERE WAS A LEAK AT THE BASE OF THE NEEDLE TOWARDS THE WING. NO SERIOUS INJURY. NO OTHER INFORMATION WAS PROVIDED. IT WAS REPORTED THIS OCCURRED WITH FIVE DEVICES. THIS REPORT ADDRESSES ALL FIVE DEVICES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21086153 ↗MalfunctionJan 6, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED BY CUSTOMER THAT WHEN FLUSHING TO PREP THE NEEDLE FOR ACCESS, THERE WAS A LEAK AT THE BASE OF THE NEEDLE TOWARDS THE WING. NO OTHER INFORMATION PROVIDED, AT THIS TIME. IT WAS REPORTED THIS OCCURRED WITH 3 DEVICES. THIS REPORT ADDRESSES ALL 3 DEVICES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21085725 ↗MalfunctionJan 2, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED BY CUSTOMER THAT WHEN FLUSHING TO PREP THE NEEDLE FOR ACCESS, THERE WAS A LEAK AT THE BASE OF THE NEEDLE TOWARDS THE WING. NO OTHER INFORMATION PROVIDED, AT THIS TIME. IT WAS REPORTED THIS OCCURRED WITH TEN DEVICES. THIS REPORT ADDRESSES ALL TEN DEVICES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21061011 ↗MalfunctionNov 7, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED BY CUSTOMER THAT WHEN FLUSHING FROM THE UPSTREAM PORT, THE CSTD ON THE Y-SITE POPPED AND WAS PULSATING ON A SUBSEQUENT PATIENT. THE PORT NEEDLE HAD BLOOD RETURN AS NORMAL. IT WAS AS IF THERE WAS AN OBSTRUCTION IN THE PORT NEEDLE THAT CAUSE TOO MUCH PRESSURE FOR THE CSTD. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20636520 ↗MalfunctionSep 28, 2024Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED VIA MEDSUN "PATIENT ARRIVED FOR PROLONGED CHEMO PUMP REMOVAL. ALERTED HIS NURSE THAT HE NOTICED SOME WETNESS TO HIS T-SHIRT, HE NOTED A WHITE, CRYSTALIZED RESIDUE IN BOTH INJECTION CAPS. HE STATES THAT HE WIPED THEM OFF WITH AN ALCOHOL WIPE. ELASTOMERIC PUMP COMPLETELY EMPTY."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20329403 ↗MalfunctionAug 15, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED BY CUSTOMER NURSE STATES THEY HAD A PATIENT SAFETY ISSUE THE OTHER DAY WITH THIS PRODUCT. ONE OF OUR PATIENTS WAS RECEIVING CONTINUOUS CHEMOTHERAPY AND WAS AT HOME WHEN THE Y-SITE ON THE TUBING OF HER PORT NEEDLE DETACHED AND COMPLETELY SEPARATED. ADDITIONAL INFORMATION RECEIVED 23-JUL-2024: THE PATIENT HAD TO STOP THEIR CONTINUOUS CHEMO AND COME IN TO GET A NEW BAG STARTED. THIS HAD A PATIENT IMPACT AND CAUSED DELAYS IN TREATMENT. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19997553 ↗MalfunctionMay 9, 2024Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED BY THE CUSTOMER FLUID LEAKED AT THE JUNCTION OF THE TUBING AND THE STEEL NEEDLE AS THE NURSE WAS PRIMING THE NEEDLE WITH SALINE PRIOR TO INSERTION. NEEDLE HAD TO BE DISCARDED PRIOR TO THE ADMINISTRATION OF CHEMO. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19278623 ↗MalfunctionJan 31, 2024Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED BY CUSTOMER THAT DURING TRANSFER OF PATIENT FROM CHAIR TO THE BED, THE PORT WAS DISLODGED, AND THE END CAP BROKE OFF. LEFT PORT DE-ACCESSED AND REMOVED. NO HARM TO PATIENT. NO OTHER INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION RECEIVED 01/23/2024: IT IS UNKNOWN IF THERE WAS ANY LEAKAGE. TREATMENT COMPLETED VIA AN ALTERNATE PERIPHERAL IV. THE NEEDLE DISLODGED FROM PORT AND DISTAL END OF PORT WAS GONE. PORT DE-ACCESSED. RN DISCOVERED DURING ASSESSMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18616798 ↗MalfunctionAug 8, 2023Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED BY CUSTOMER, THAT PROXIMAL ACCESS POINT LEAKS LIQUID WHEN NEEDLE FLUSHED FROM DISTAL ACCESS POINT. AND FOAMY BLOOD IS NOTED, WHEN DRAWN BLOOD FROM PROXIMAL LUMENS. THIS IS OCCURRING WITH THE 3/4-INCH NEEDLES. IT WAS REPORTED, THIS OCCURRED WITH 4 DEVICES. THIS REPORT ADDRESSES THE THIRD DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17483460 ↗MalfunctionAug 8, 2023Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED BY CUSTOMER THAT PROXIMAL ACCESS POINT LEAKS LIQUID WHEN NEEDLE FLUSHED FROM DISTAL ACCESS POINT AND FOAMY BLOOD IS NOTED WHEN DRAWN BLOOD FROM PROXIMAL LUMENS. THIS IS OCCURRING WITH THE 3/4-INCH NEEDLES. IT WAS REPORTED THIS OCCURRED WITH 4 DEVICES. THIS REPORT ADDRESSES THE FOURTH DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17483455 ↗MalfunctionAug 8, 2023Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED BY CUSTOMER THAT PROXIMAL ACCESS POINT LEAKS LIQUID WHEN NEEDLE FLUSHED FROM DISTAL ACCESS POINT AND FOAMY BLOOD IS NOTED WHEN DRAWN BLOOD FROM PROXIMAL LUMENS. THIS IS OCCURRING WITH THE 3/4-INCH NEEDLES. IT WAS REPORTED THIS OCCURRED WITH 4 DEVICES. THIS REPORT ADDRESSES THE SECOND DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17483452 ↗MalfunctionAug 8, 2023Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED BY CUSTOMER THAT PROXIMAL ACCESS POINT LEAKS LIQUID WHEN NEEDLE FLUSHED FROM DISTAL ACCESS POINT AND FOAMY BLOOD IS NOTED WHEN DRAWN BLOOD FROM PROXIMAL LUMENS. THIS IS OCCURRING WITH THE 3/4-INCH NEEDLES. IT WAS REPORTED THIS OCCURRED WITH 4 DEVICES. THIS REPORT ADDRESSES THE FIRST DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17483442 ↗MalfunctionJun 8, 2023Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED BY CUSTOMER CRACKED AND LEAKED AT THE Y WHEN FLUSHED. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: Insufficient Information
MAUDE report 17089768 ↗MalfunctionMay 26, 2023Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED VIA MEDWATCH "A HUBER NEEDLE NOTED LEAKING FROM Y-SITE PORT OF THE HUBER NEEDLE TUBING. NOTED A SMALL CRACK AT THE Y-SITE. NEEDLE AND TUBING USED FOR CHEMOTHERAPY ADMINISTRATION." NO OTHER INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION RECEIVED 05/17/2023: THE EVENT DID NOT INVOLVE AN URGENT OR LIFE THREATENING MEDICAL CONDITION. THE LEAK WAS DISCOVERED BY STAFF DURING CLINICAL CARE. THERE WAS NO INTERRUPTION OR SIGNIFICANT DELAY IN TREATMENT THAT NEGATIVELY IMPACTED THE PATIENT. THERE WERE NO SIGNS, SYMPTOMS, COMPLICATIONS EXPERIENCED. SKIN WAS CLEANSED WHERE TUBING LEAKED. CATHETER SECURED WITH HYDROPHILIC POLYURETHANE (TRANSPARENT) DRESSING AND TAPE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17011607 ↗MalfunctionMay 12, 2023Crack; Crack
IT WAS REPORTED VIA MEDWATCH "Y-SITE ON BARD POWERLOC DEVICE LEAKING. DEVICE AVAILABLE FOR RETURN." ADDITIONAL INFORMATION RECEIVED 4/28/2023: CUSTOMER REPORTED LEAK WHILE PATIENT WAS ADMITTED TO THE HOSPITAL. NO SIGNIFICANT MEDICAL IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16924583 ↗MalfunctionApr 21, 2023Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED BY THE CUSTOMER "INFUSION SET LEAKING." NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16791007 ↗MalfunctionApr 21, 2023Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED BY THE CUSTOMER "INFUSION SET LEAKING." NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16790781 ↗MalfunctionApr 21, 2023Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED BY THE CUSTOMER "INFUSION SET LEAKING." NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16790730 ↗MalfunctionApr 21, 2023Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED BY THE CUSTOMER "INFUSION SET LEAKING." NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16790715 ↗MalfunctionApr 21, 2023Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED BY THE CUSTOMER THEY HAVE A Y- SITE LEAKING FROM A POWERLOC NEEDLE. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16790704 ↗MalfunctionApr 19, 2023Activation Problem; Activation Problem
IT WAS REPORTED BY THE CUSTOMER THAT "DIFFICULTY ENGAGING THE SAFETY MECHANISM EXPOSING RISK FOR NEEDLE STICK INJURY". NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16769314 ↗MalfunctionMar 26, 2023Crack; Crack
IT WAS REPORTED BY THE CUSTOMER THAT "RN THAT INITIATED PATIENT'S TREATMENT & ACCESSED HER PORT FIRST THING THIS AM SAID THERE WERE NO ISSUES WITH THE EXTENSION SET. SHE PRIMED THE SET, ACCESSED THE PORT, DREW BLOOD SPECIMEN FROM THE EXTENSION SET & HOOKED UP HER MAGNESIUM INFUSION WITHOUT INCIDENT. WHEN ANOTHER RN RESPONDED TO AN IV PUMP ALARM FOR DOWNSTREAM OCCLUSION THE RN SAID SHE FOUND ONE OF THE CLAMPS ON THE EXTENSION SET TO BE CLAMPED. SHE UNCLAMPED THE CLAMP & FINISHED THE INFUSION. UNKNOWN HOW THIS CLAMP GOT ENGAGED. THIS SAME RN THEN DISCONTINUED THE INFUSION WHEN IT RANG COMPLETE AT WHICH TIME THE PATIENT REPORTED TO HER THAT HER SHIRT WAS WET. WHEN THE RN COMPLETED THE POST INFUSION FLUSH TO THE PORT SHE NOTICED SALINE TO BE SQUIRTING OUT FROM THE Y SITE AREA ON THE EXTENSION SET. IT IS UNKNOWN WHEN THIS LEAKING BEGAN OR HOW MUCH OF THE MEDICATION LEAKED OUT. EXTENSION TUBING."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16616801 ↗MalfunctionMar 8, 2023Activation Problem; Activation Problem
IT WAS REPORTED BY THE CUSTOMER "THE NEEDLE DOES NOT CLICK PROPERLY." NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16500574 ↗
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