Port Access Needle 0142210Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00801741047473), received between Jul 15, 2020 and Jan 14, 2021 — 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Recalls naming this device

1. 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 · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 14, 2021Break; Crack; Material Split, Cut or Torn; Break

  IT WAS REPORTED POWERLOC NEEDLE TUBING CRACKED. ADDITIONAL DETAILS RECEIVED VIA PHONE CALL WITH THE PATIENT: IT WAS REPORTED "THE TUBING WAS SEVERED BY THE HUB WHERE THE PLASTIC MEETS THE TUBING. THIS IS THE ONLY TIME THAT WE USED THIS NEEDLE. THIS IS A NEW PORT, I HAVE USED OTHER BRANDS OF NEEDLES BEFORE AND SINCE, I NEVER HAVE HAD A PROBLEM ONLY WITH THIS NEEDLE." ADDITIONAL INFORMATION RECEIVED: "A DETAILED DESCRIPTION OF THE EVENT: WHEN THE PATIENT TRIED TO ACCESS HER PORT, THE POWERLOC MAX HUBER NEEDLE TUBING SPLIT. PATIENT COULD NOT ACCESS HER PORT, AND HER MEDICATION COULD NOT BE ADMINISTERED. " "WAS THERE PATIENT HARM REPORTED? NO DIRECT PATIENT HARM WAS REPORTED WITH THIS INCIDENT. PATIENT WAS EMOTIONALLY DISTRAUGHT, AS SHE HAS HAD THIS OCCUR WITH THE LAST RECALL, AND SHE ENDED UP NEEDING A SURGICAL REPLACEMENT OF HER PORT. SHE WAS ALSO UNABLE TO ADMINISTER HER MEDICATION UNTIL A NURSE WAS ABLE TO EMERGENTLY SEE HER. "

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11171580 ↗
• InjurySep 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE USE OF POWERLOC MAX 22GA X 1 IN. NEEDLE CAUSED A PATIENT TO BE HOSPITALIZED WITH BACTEREMIA AND SUBSEQUENT PORT REPLACEMENT. MEDWATCH RCVD 09/15/2020: PATIENT REPORTED THAT HUBER POWERLOC NEEDLE LINE IS SPLITTING. SHE SWITCHED TO SAFESTEP, WHICH WAS ALSO SPLITTING. THEN A RECALL ON THESE PRODUCTS WAS RELEASED. THE PATIENT DEVELOPED SWELLING AND A LUMP AT HER PORT SITE. SHE THEN DEVELOPED FEVER AND WAS HOSPITALIZED. HER PORT IS BEING REMOVED AND A MIDLINE WILL IV WILL BE PLACED SO THAT SHE RECEIVE IV ANTIBIOTICS. MORE INFORMATION TO FOLLOW AFTER SHE IS RELEASED FROM THE HOSPITAL AND WE CAN GET A FULL TIME LINE OF EVENTS AND LOT NUMBERS. HUBER POWERLOC 22GX1 (LOT# ASCYF018, ASCYF019, ASCZF026, ASDRF047, ASDRF048, ASDRF049, ASDRF050) HUBER SAFESTEP 22X0.5 (LOT# ASCYF013, ASCYF014, ASCZF029, ASCVF035, ASCVF038, ASCVF042); HUBER SAFESTEP 22X1 (LOT# ASDNF034, ASDNF049, ASDNF055, ASDPF015, ASDPF017, ASDPF024, ASDPF025, ASDPF026, ASDQF017, ASDRF066, ASDRF066, ASDUF120, ASDVF004, ASDVF009, ASDVF013, ASDVF016, ASDVF025).

  Patient problems: Sepsis

  MAUDE report 10518404 ↗
• MalfunctionJul 15, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT POST PORT IMPLANT AND DURING THE USAGE OF SAFETY INFUSION SET TO ACCESS THE PORT, TWO INFUSION SETS HAVE BEEN FOUND TO BREAK, LEAK AND THE CLAMPS WERE NOT FOUND TO BE WORKING. THERE HAS BEEN NO REPORTED PATIENT INJURY. THIS REPORT ADDRESSES THE FIRST DEVICE. MEDWATCH RCVD (B)(6)2020: PATIENT REPORTED THAT HUBER POWERLOC NEEDLE LINE IS SPLITTING. SHE SWITCHED TO SAFESTEP, WHICH WAS ALSO SPLITTING. THEN A RECALL ON THESE PRODUCTS WAS RELEASED. THE PATIENT DEVELOPED SWELLING AND A LUMP AT HER PORT SITE. SHE THEN DEVELOPED FEVER AND WAS HOSPITALIZED. HER PORT IS BEING REMOVED AND A MIDLINE WILL IV WILL BE PLACED SO THAT SHE RECEIVE IV ANTIBIOTICS. MORE INFORMATION TO FOLLOW AFTER SHE IS RELEASED FROM THE HOSPITAL AND WE CAN GET A FULL TIME LINE OF EVENTS AND LOT NUMBERS. HUBER POWERLOC 22GX1 (LOT# ASCYF018, ASCYF019, ASCZF026, ASDRF047, ASDRF048, ASDRF049, ASDRF050) HUBER SAFESTEP 22X0.5 (LOT# ASCYF013, ASCYF014, ASCZF029, ASCVF035, ASCVF038, ASCVF042); HUBER SAFESTEP 22X1 (LOT# ASDNF034, ASDNF049, ASDNF055, ASDPF015, ASDPF017, ASDPF024, ASDPF025, ASDPF026, ASDQF017, ASDRF066, ASDRF066, ASDUF120, ASDVF004, ASDVF009, ASDVF013, ASDVF016, ASDVF025)

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10279499 ↗
• MalfunctionJul 15, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT POST PORT IMPLANT AND DURING THE USAGE OF SAFETY INFUSION SET TO ACCESS THE PORT, TWO INFUSION SETS HAVE BEEN FOUND TO BREAK, LEAK AND THE CLAMPS WERE NOT FOUND TO BE WORKING. THERE HAS BEEN NO REPORTED PATIENT INJURY. THIS REPORT ADDRESSES THE SECOND DEVICE. MEDWATCH RCVD 09/15/2020: PATIENT REPORTED THAT HUBER POWERLOC NEEDLE LINE IS SPLITTING. SHE SWITCHED TO SAFESTEP, WHICH WAS ALSO SPLITTING. THEN A RECALL ON THESE PRODUCTS WAS RELEASED. THE PATIENT DEVELOPED SWELLING AND A LUMP AT HER PORT SITE. SHE THEN DEVELOPED FEVER AND WAS HOSPITALIZED. HER PORT IS BEING REMOVED AND A MIDLINE WILL IV WILL BE PLACED SO THAT SHE RECEIVE IV ANTIBIOTICS. MORE INFORMATION TO FOLLOW AFTER SHE IS RELEASED FROM THE HOSPITAL AND WE CAN GET A FULL TIME LINE OF EVENTS AND LOT NUMBERS. HUBER POWERLOC 22GX1 (LOT# ASCYF018, ASCYF019, ASCZF026, ASDRF047, ASDRF048, ASDRF049, ASDRF050) HUBER SAFESTEP 22X0.5 (LOT# ASCYF013, ASCYF014, ASCZF029, ASCVF035, ASCVF038, ASCVF042); HUBER SAFESTEP 22X1 (LOT# ASDNF034, ASDNF049, ASDNF055, ASDPF015, ASDPF017, ASDPF024, ASDPF025, ASDPF026, ASDQF017, ASDRF066, ASDRF066, ASDUF120, ASDVF004, ASDVF009, ASDVF013, ASDVF016, ASDVF025)

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10279414 ↗