Port Access Needle 0142275Recalls & reported problems
Bard Access Systems, Inc. · PowerLoc Max 22G x 0.75 inch · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This Bard PowerLoc Max port access needle is used to access implanted ports. The 25 reports mainly describe tubing cracking or breaking, causing leaks; there were no deaths or injuries. There is 1 recall, now closed, that began in June 2020 because tubing near connector points could crack or break and leak medicines or blood. Reports declined from 2 in the previous 12 months to 0 in the latest 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
- 25
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 00801741047497), received between Jan 24, 2020 and Dec 30, 2024 — classified as 25 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (20 reports).
1 FDA recall record name this device's identifier.
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.
Reports received per month
Recalls naming this device
- Jun 19, 2020Terminated
Potential development of cracks or breaks in the tubing near the Luer or Y site of the device. Devices that have developed breaks or cracks can cause leakage resulting in exposure to chemicals such a chemotherapeutics or biohazard material (e.g., blood). A crack or break could result in potential blood loss, catheter occlusion, air embolism, under or interrupted infusion, or site contamination which could lead to infection.
Z-2670-2020 · Root cause: Process control · FDA record ↗
Most reported problems
Device problems
- Fluid/Blood Leak20
- Break6
- Crack1
Patient problems
- No Clinical Signs, Symptoms or Conditions14
- No Consequences Or Impact To Patient10
- Insufficient Information1
Recent adverse event reports
The 25 most recent of 25 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 30, 2024Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED BY THE CUSTOMER THE HUBER PORT NEEDLE CRACKED AT THE TUBING. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21036245 ↗MalfunctionNov 24, 2024Break; Break
IT WAS REPORTED BY CUSTOMER THAT TUBING BREAKAGES. ¾ IN PAC NEEDLE BROKEN AT HUB NEAR CAP, HAD TO REACCESS PORT IN THE MIDDLE OF THE NIGHT D/T TUBING BREAKING REQUIRING A REPLACEMENT. NO OTHER INFORMATION PROVIDED, AT THIS TIME. A SPECIFIC NUMBER OF AFFECTED DEVICES OR PATIENTS WAS NOT PROVIDED BY THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20767943 ↗MalfunctionSep 11, 2024Break; Break
IT WAS REPORTED BY CUSTOMER THAT PAC NEEDLE BROKE AT HUB NEAR CAP. NO PATIENT HARM OR COMPLICATIONS REPORTED. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20191378 ↗MalfunctionSep 6, 2024Break; Break
IT WAS REPORTED THAT PAC TUBING BROKE AT THE DISTAL END FROM NEEDLE WHERE CAP WOULD BE SCREWED INTO WHILE PATIENT WAS AT HOME ACCESSING PAC WITH BLINITUMAMAB INFUSING USING HOME CADD PUMP. NO PATIENT HARM OR COMPLICATIONS REPORTED. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20164292 ↗MalfunctionApr 17, 2024Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED CRACK IN THE TUBING FROM THE PORT NEEDLE. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19127730 ↗MalfunctionMar 15, 2024Break; Break
IT WAS REPORTED BY CUSTOMER THAT, "WE'VE STARTED SEEING A TREND AT FACILITY WITH NEEDLE. WE'VE HAD REPEATED INSTANCES CRACKED TUBING WITH LEAKING." NO OTHER INFORMATION WAS PROVIDED. A SPECIFIC NUMBER OF AFFECTED DEVICES OR PATIENTS WAS NOT PROVIDED BY THE COMPLAINANT. TWO DEVICES WERE RETURNED FOR EVALUATION. THIS REPORT ADDRESSES THE SECOND DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18916367 ↗MalfunctionFeb 27, 2024Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT CUSTOMER STARTED SEEING A TREND WITH THE PORT A CATH NEEDLE (22G X 0.75 IN.): REPEATED INSTANCES OF CRACKED TUBING WITH LEAKING. A SPECIFIC NUMBER OF AFFECTED DEVICES OR PATIENTS WAS NOT PROVIDED BY THE COMPLAINANT. FIVE DEVICES WERE RETURNED FOR EVALUATION. THIS REPORT ADDRESSES THE FIFTH DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18794576 ↗MalfunctionFeb 27, 2024Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT CUSTOMER STARTED SEEING A TREND WITH THE PORT A CATH NEEDLE (22G X 0.75 IN.): REPEATED INSTANCES OF CRACKED TUBING WITH LEAKING. A SPECIFIC NUMBER OF AFFECTED DEVICES OR PATIENTS WAS NOT PROVIDED BY THE COMPLAINANT. FIVE DEVICES WERE RETURNED FOR EVALUATION. THIS REPORT ADDRESSES THE FOURTH DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18794548 ↗MalfunctionFeb 27, 2024Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT CUSTOMER STARTED SEEING A TREND WITH THE PORT A CATH NEEDLE (22G X 0.75 IN.): REPEATED INSTANCES OF CRACKED TUBING WITH LEAKING. A SPECIFIC NUMBER OF AFFECTED DEVICES OR PATIENTS WAS NOT PROVIDED BY THE COMPLAINANT. FIVE DEVICES WERE RETURNED FOR EVALUATION. THIS REPORT ADDRESSES THE THIRD DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18794547 ↗MalfunctionFeb 27, 2024Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT CUSTOMER STARTED SEEING A TREND WITH THE PORT A CATH NEEDLE (22G X 0.75 IN.): REPEATED INSTANCES OF CRACKED TUBING WITH LEAKING. A SPECIFIC NUMBER OF AFFECTED DEVICES OR PATIENTS WAS NOT PROVIDED BY THE COMPLAINANT. FIVE DEVICES WERE RETURNED FOR INVESTIGATION. THIS REPORT ADDRESSES THE SECOND DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18794542 ↗MalfunctionJan 23, 2024Break; Fluid/Blood Leak; Break; Fluid/Blood Leak
IT WAS REPORTED BY CUSTOMER THAT, "WE'VE STARTED SEEING A TREND AT FACILITY WITH NEEDLE. WE'VE HAD REPEATED INSTANCES CRACKED TUBING WITH LEAKING." NO OTHER INFORMATION WAS PROVIDED. A SPECIFIC NUMBER OF AFFECTED DEVICES OR PATIENTS WAS NOT PROVIDED BY THE COMPLAINANT. TWO DEVICES WERE RETURNED FOR EVALUATION. THIS REPORT ADDRESSES THE FIRST DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18566793 ↗MalfunctionDec 5, 2023Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT CUSTOMER STARTED SEEING A TREND WITH THE PORT A CATH NEEDLE (22G X 0.75 IN.): REPEATED INSTANCES OF CRACKED TUBING WITH LEAKING. A SPECIFIC NUMBER OF AFFECTED DEVICES OR PATIENTS WAS NOT PROVIDED BY THE COMPLAINANT. FIVE DEVICES WERE RETURNED FOR INVESTIGATION. THIS REPORT ADDRESSES THE FIRST DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18271621 ↗MalfunctionNov 9, 2022Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED BY THE CUSTOMER "A TEGADERM DRESSING IS APPLIED TO THE PORT, BUT THE DISTAL END OF THE LINE WHERE IT MEETS THE CLAVE IS WHERE THE BREAK IS OCCURRING AND THIS PORTION HANGS DOWN BELOW THE DRESSING. OCCURRED IN PEDIATRIC DEPARTMENT."
Patient problems: Insufficient Information
MAUDE report 15762700 ↗MalfunctionApr 2, 2021Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THE MOM OF THE PATIENT STATED THE PORT NEEDLE LEAKED AT THE CONNECTION OF THE CLAVE HUB AND TUBING AT HOME ABOUT A MONTH AGO. ADD INFO RCVD (B)(6) 2021: MOM WAS AT HOME WITH THAT PATIENT AND FLUSHED THE PORT WITH A 10 ML SYRINGE OF SALINE. DURING THE FLUSH THE TUBING STATED TO LEAK WHERE THE LEUR LOCK CONNECTS TO THE TUBING (DISTAL TO THE PATIENT). MOM CLAMPED THE TUBING AND BROUGHT THE PATIENT IN FOR A NEEDLE CHANGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11609239 ↗MalfunctionApr 2, 2021Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED "I WENT TO FLUSH A POWER PORT ON A PATIENT AND THE [NEEDLE] TUBING STARTED TO LEAK. IT LEAKS AT THE CONNECTION OF THE CLAVE HUB AND THE TUBING, WHICH IS DISTAL TO THE PATIENT."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11609016 ↗MalfunctionMar 25, 2020Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT THE TUBING ON THE PORT ACCESS NEEDLE CRACKED. NO OTHER INFORMATION WAS PROVIDED. (B)(6) 2020 - PER AIR: "PATIENT PORT TUBING DISTAL TO THE NEEDLE BUT ABOVE THE CAP HAD A SMALL HOLE. WHEN [COMPLAINANT] WENT TO DRAW LABS, UPON FLUSHING NORMAL SALINE, I DISCOVERED THAT SALINE WAS SQUIRTING OUT OF THE HOLE."
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9880016 ↗MalfunctionMar 25, 2020Crack
IT WAS REPORTED THAT THE TUBING ON THE PORT ACCESS NEEDLE CRACKED. (B)(6)2020 - PER AIR: "BEDSIDE NURSE WAS CALLED INTO PATIENT ROOM BY FATHER. FATHER NOTICED BLOOD COMING BACK ON PORT TUBING. PORT TUBING WAS RUNNING D5NS @10ML PER HOUR. NURSE SAW BLOOD HAD BACKED OUT A LITTLE FROM THE PORT SITE AND HAD DRIPPED ON PATIENT. RN CHECKED LINE AND FLUSHED AND SAW FLUID SQUIRTING OUT. THIS WAS BELOW THE NEEDLELESS CONNECTOR ON THE PORT TUBING (NOT ATTACHED IV TUBING BUT CLOSEST TO THE PATIENT). RN IMMEDIATELY CALLED FOR HELP. LINE WAS DE-ACCESSED AND RE-ACCESSED WITH NEW NEEDLE, BLOOD CULTURES WERE DRAWN AT THE TIME. NEW TUBING WAS USED. NP NOTIFIED. BROKEN PORT TUBING WAS POWERLOC MAX 22G 3/4 INCH. REPLACEMENT PORT DEVICE (DIFFERENT NEEDLE THAN POWERLOC MAX AS PART OF A TRIAL OF NEW NEEDLES DUE TO FREQUENT BREAKAGE ISSUES ON POWERLOC MAX). SOON AFTER NEW PORT WAS PLACED, PATIENT RECEIVED IV CHEMO. ALL 22G X 3/4 INCH NEEDLES WERE REMOVED FROM STOCK ROOM."
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9878342 ↗MalfunctionMar 25, 2020Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT THE TUBING ON THE PORT ACCESS NEEDLE CRACKED. (B)(6) 2020 - PER AIR: "PATIENT'S MOM CALLED OUT STATING IV LEAKING. UPON ASSESSMENT, MOM HAD TISSUE AT PORT SITE WHERE THE TUBING OF THE PORT CONNECTS TO THE HUB PART OF THE END OF THE PORT (NOT THE NEEDLE END). [COMPLAINANT] NOTED THERE WAS A CRACK AND FLUID WAS LEAKING. CLAMPED PORT AND COVERED LEAKING SECTION WITH GAUZE AND NOTIFIED TEAM. PER MOM, SHE WAS HELPING [PATIENT] UP TO THE BATHROOM WHEN SHE FELT SOME WETNESS AND REALIZED IT WAS THE PATIENT'S LINE LEAKING. PROVIDERS ORDER BLOOD CULTURES. DE-ACCESSED LINE, DREW BLOOD CULTURES, AND HEPLOCKED THE LINE."
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9878120 ↗MalfunctionFeb 28, 2020Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT THE POWERLOC TUBING CRACKED AND CAUSED LEAKAGE. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9772125 ↗MalfunctionJan 24, 2020Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT THE TUBING CRACKED AT THE HUB CAUSING LEAKAGE ON TWO POWERLOC NEEDLES. NO OTHER INFORMATION WAS PROVIDED. THIS REPORT ADDRESSES THE FIRST NEEDLE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9627677 ↗MalfunctionJan 24, 2020Break; Fluid/Blood Leak; Break; Fluid/Blood Leak
IT WAS REPORTED THAT THE TUBING CRACKED AT THE HUB CAUSING LEAKAGE. NO OTHER INFORMATION PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9627675 ↗MalfunctionJan 24, 2020Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT THE TUBING CRACKED AT THE HUB CAUSING LEAKAGE ON TWO POWERLOC NEEDLES. NO OTHER INFORMATION WAS PROVIDED. THIS REPORT ADDRESSES THE SECOND NEEDLE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9627673 ↗MalfunctionJan 24, 2020Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT THE TUBING CRACKED AT THE HUB CAUSING LEAKAGE. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9627669 ↗MalfunctionJan 24, 2020Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT THE TUBING CRACKED AT THE HUB CAUSING LEAKAGE. NO OTHER INFORMATION PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9627667 ↗MalfunctionJan 24, 2020Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT THE TUBING CRACKED AT THE HUB CAUSING LEAKAGE. NO OTHER INFORMATION PROVIDED. (B)(6) 2020 - PER AIR RECEIVED: PATIENT HAD PORT TUBING BREAK AGAIN - 24 HOURS AFTER BEING ADMITTED. THIS TIME CHEMO WAS INFUSING. PARENTS NOTICED A DROP OF METHOTREXATE CHEMO AND NOTIFIED NURSE. NURSE STOPPED CHEMO. ACCORDING TO NURSES, TUBING BROKE ABOVE NEEDLELESS CONNECTOR. COMPLAINANT BELIEVES THIS IS THE SAME PLACE IT HAS BROKEN MULTIPLE TIMES IN THE PAST. PATIENT HAD TO BE DE-ACCESSED, RE-ACCESSED, BLOOD CULTURES WERE DRAW. REMINDER OF THE CHEMO TUBING WAS SENT BACK TO PHARMACY, PLACED IN A NEW BAG AND RESTARTED LATER THAT DAY. THIS MAY BE THE 5TH TIME THIS HAS HAPPENED. COMPLAINANT DOESN'T THINK THERE'S BEEN ANY CHANGE. THE DAY BEFORE, WHEN THE PATIENT WAS ADMITTED, THE RN NOTIFIED THE BEDSIDE RN ABOUT HER EXPERIENCES WITH THE PATIENT'S PORT. UNFORTUNATELY, IT WAS A VERY BUSY DAY. COMPLAINANT IS NOT SURE HOW THE PORT WAS TAPED OR IF IT WAS TAPED ANY DIFFERENTLY. COMPLAINANT WAS NOT PROVIDING DIRECT CARE TO THE PATIENT. THE NEXT DAY, THE COMPLAINANT REPORTED SHE HAPPENED TO WALK BY RIGHT WHEN THE PATIENT'S PORT NEEDLE HAD BROKEN SO SHE TOLD THE NURSE FOR THAT DAY THAT HIS HAS H
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9627582 ↗
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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