Port Access Needle 0142015Recalls & reported problems
Bard Access Systems, Inc. · PowerLoc Max 20G x 1.5 inch · Class 2
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00801741047459), received between Jun 18, 2024 and Feb 11, 2025 — classified as 1 injury, 3 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (2 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 Leak2
- Adverse Event Without Identified Device or Use Problem1
- Break1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Air Embolism1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryFeb 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT CLINICIAN ENCOUNTERED AIR-EMBOLISM WHILE USING THE BD POWERLOC¿ MAX POWER INJECTABLE SAFETY INFUSION SET (20GA × 1.0 INCHES / 25 MM) WITH Y-SITE INSERTED THROUGH SEPTUM OF SURGICALLY IMPLANTED PORT FOR ADMINISTRATION OF FLUIDS, MEDICATIONS / DRUGS, AND BLOOD SAMPLING. THE EVENT DID NOT RESULT IN THE REMOVAL OF THE POWERLOC MAX. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: Air Embolism
MAUDE report 21360973 ↗MalfunctionNov 20, 2024Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED VIA MEDSUN THAT TUBING ATTACHED TO PORT HUBER NEEDLE TORE WHILE ACCESSING PORT FOR CONTINUAL CHEMOTHERAPY. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20737724 ↗MalfunctionJun 18, 2024Break; Break
IT WAS REPORTED WE HAD A PATIENT INFUSING BLINATUMOMAB AND THE TUBING BROKE OFF JUST BELOW THE NEEDLESS CONNECTOR END. I DO NOT HAVE THE LOT NUMBERS FOR THESE PRODUCTS. WE USE THE POWERLOC MAX POWER INJECTABLE INFUSION SET, REF (B)(4). ADDITIONAL INFORMATION 05/28/2024: NO PATIENT HARM HAS BEEN DISCOVERED. THIS DID CREATE A WINDOW FOR INFECTION, BUT PATIENT HAD NO SIGNS OF POSITIVE CULTURES. MEDICATION WAS NOT WASTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19560068 ↗MalfunctionJun 18, 2024Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED, "WE HAD A PATIENT INFUSING BLINATUMOMAB AND THEIR MEDI PORT TUBING CRACKED. WE USE THE POWERLOC MAX POWER INJECTABLE INFUSION SET, REF 0142015." ADDITIONAL INFORMATION 05/28/2024: PATIENT HAD NO SIGNS OF POSITIVE CULTURES. MEDICATION WAS NOT WASTED. NO PATIENT HARM NOTED AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19558519 ↗
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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.