Port Access Needle 0131975Recalls & reported problems

Summary

The FDA's MAUDE database contains 38 adverse event reports that list this exact device (DI 00801741047343), received between Jun 1, 2018 and Oct 25, 2023 — classified as 38 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (21 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 25 most recent of 38 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 25, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY THE CUSTOMER THAT THE PRODUCT IS AN AUTO SUB WITH A Y SITE AND A LEAK WAS REPORTED AT THE Y SITE DESPITE HAVING AN END CAP PUT ON IT AND THERE WAS ALSO A LEAK AT THE ACTUAL SITE WHERE THE HUB WAS INSERTED INTO THE PATIENTS PORT. RESPONSE RECEIVED ON (B)(6) 2023. NO PATIENT INFORMATION AVAILABLE DUE TO PATIENT CONFIDENTIALITY. NO APPARENT HARM REPORTED. ADDITIONAL INFORMATION RECEIVED 10/11/2023: IT WAS SALINE IN THE LINE AND IT WAS SECURED WITH A TEGADERM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18007012 ↗
• MalfunctionOct 25, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY THE CUSTOMER THAT THE PRODUCT IS AN AUTO SUB WITH A Y SITE AND A LEAK WAS REPORTED AT THE Y SITE DESPITE HAVING AN END CAP PUT ON IT AND THERE WAS ALSO A LEAK AT THE ACTUAL SITE WHERE THE HUB WAS INSERTED INTO THE PATIENTS PORT. RESPONSE RECEIVED ON (B)(6) 2023. NO PATIENT INFORMATION AVAILABLE DUE TO PATIENT CONFIDENTIALITY. NO APPARENT HARM REPORTED. ADDITIONAL INFORMATION RECEIVED 10/11/2023: IT WAS SALINE IN THE LINE AND IT WAS SECURED WITH A TEGADERM.

  Patient problems: Insufficient Information

  MAUDE report 18006024 ↗
• MalfunctionAug 14, 2023Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED RAB LAB RN WAS IN THE PROCESS OF PREPARING TO ACCESS A PORT WHEN SHE NOTED THAT THE POWERLOCMAX INFUSION SET WAS CONTAMINATED STRAIGHT OUT OF A SEALED PACKAGE; THERE WAS A DARK SPOT WITHIN THE INNER DIAMETER OF THE LUER LOCK CONNECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17540519 ↗
• MalfunctionJun 2, 2023Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  IT WAS REPORTED BY CUSTOMER THAT THEY HAD A BROKEN HUBER NEEDLE OVERNIGHT UP ON THE UNIT. IT WAS A 0.75, 19G. IT HAD 0.9NS AT 242ML/HR AND POTASSIUM AT 25ML/HR RUNNING THROUGH IT. THE NEEDLE WAS 3 DAYS OLD. ADDITIONAL INFORMATION RECEIVED 5/23/2023: IT WAS REPORTED "IT WAS DISCOVERED BY THE PATIENT BECAUSE IT WAS LEAKING ALL OVER THE PATIENT. PATIENT REQUIRED A RECANNULATION OF THEIR PORT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17055825 ↗
• MalfunctionApr 7, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY THE CUSTOMER THE TUBING OF THE INFUSION SET CRACKED AND CAUSED LEAKAGE OF SOLUTION. ADDITIONAL INFORMATION PROVIDED VIA MEDWATCH, "IT WAS BROUGHT TO OUT ATTENTION THAT THE TUBING ON THE BECTON DIXON MEDICAL POWERLOC MAX POWER INJECTABLE INFUSION SET WAS CRACKED AT THE Y CONNECTION SITE CAUSING LEAKAGE OF SOLUTION."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16698911 ↗
• MalfunctionMar 22, 2023Crack; Crack

  IT WAS REPORTED BY THE CUSTOMER "ONE OF MY PATIENT'S PORT NEEDLES CRACKED AT BOTH Y-SITES." 03/07/2023 ADDITIONAL INFORMATION PROVIDED: IT WAS REPORTED BY THE CUSTOMER "THE PATIENT DID NOT HAVE ANYTHING INFUSING WHILE UP ON THE FLOOR. HIS PORT WAS HEP LOCKED BUT HE WENT DOWN FOR CT AND THEY TRIED INFUSING THE CONTRAST DYE AND IMMEDIATELY NOTICED IT WAS LEAKING AT BOTH Y-SITES. IT WAS A 19G 1 INCH NEEDLE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16590584 ↗
• MalfunctionMar 9, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY THE CUSTOMER THE HUBER NEEDLE BROKE OVER THE WEEKEND. IT WAS ACCESSED FOR ~5 DAYS AND WAS A 19G, 0.75 INCH NEEDLE." NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16519392 ↗
• MalfunctionMar 3, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THERE WAS A BROKEN HUBER NEEDLE OVER THE WEEKEND. IT WAS AT THE JUNCTION WHERE THE Y PORT COMES OFF THE SIDE. AFTER 40 HOURS AFTER BEING ACCESSED IT BEGAN LEAKING W/ 0.9NS W/ BICARB IN IT THAT WAS RUNNING AT 83ML/HR. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16478854 ↗
• MalfunctionMar 2, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THERE WAS A BROKEN HUBER NEEDLE OVER THE WEEKEND. IT WAS AT THE JUNCTION WHERE THE Y PORT COMES OFF THE SIDE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 16475653 ↗
• MalfunctionFeb 24, 2023Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  IT WAS REPORTED BY THE CUSTOMER "MEDICATION LEAKAGE AT THE Y INJECTIONS SITE." NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 16440815 ↗
• MalfunctionFeb 20, 2023Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  IT WAS REPORTED BY THE CUSTOMER "A HUBER NEEDLE LEAKED OVERNIGHT LAST NIGHT. NEEDLE WAS ONLY IN PLACE FOR <24 HOURS, PATIENT HAD ANTIBIOTIC INFUSION WHEN LEAKING STARTED." NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16401872 ↗
• MalfunctionNov 29, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY THE CUSTOMER "OVER THE PAST TWO WEEKS WE HAVE 2 DIFFERENT INCIDENCE OF HUBER NEEDLES THAT WE USE IN PORT A CATHS LEAKING OUT OF PART OF THE TUBING ON THE DEVICE." ADDITIONAL INFORMATION "THE EVENT(S) OCCURRED WITHIN 12 HOURS OF THE DEVICE BEING INSERTED INTO THE PATIENT AND WERE IDENTIFIED WHEN THE RN WAS FLUSHING THE Y PORT ON THE HUBER NEEDLE.¿ THIS REPORT ADDRESSES THE SECOND DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15881048 ↗
• MalfunctionNov 29, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY THE CUSTOMER "OVER THE PAST TWO WEEKS WE HAVE 2 DIFFERENT INCIDENCE OF HUBER NEEDLES THAT WE USE IN PORT A CATHS LEAKING OUT OF PART OF THE TUBING ON THE DEVICE." ADDITIONAL INFORMATION "THE EVENT(S) OCCURRED WITHIN 12 HOURS OF THE DEVICE BEING INSERTED INTO THE PATIENT AND WERE IDENTIFIED WHEN THE RN WAS FLUSHING THE Y PORT ON THE HUBER NEEDLE.¿ THIS REPORT ADDRESSES THE FIRST DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15880682 ↗
• MalfunctionJul 20, 2022Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  IT WAS REPORTED BY NURSE ¿PATIENT HAD THE DEVICE INSERTED ON (B)(6) 2022 AND LEFT OVER NIGHT FOR TREATMENT. WHEN THE NURSE WENT TO FLUSH THE LINE ON (B)(6), THERE WAS LEAKING OUT OF THE TUBING, NO TYPE OF HARM INVOLVED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15065113 ↗
• MalfunctionJul 13, 2022Material Twisted/Bent; Activation Problem; Material Twisted/Bent; Activation Problem

  IT WAS REPORTED "WHILE DE-ACCESSING A PORT, THE NEEDLE WOULD NOT FULLY RETRACT TO LOCK THE NEEDLE IN THE SAFETY DEVICE. THE PORT NEEDLE WAS PULLED OUT WITHOUT ANY INJURY TO THE PATIENT OR NURSE" ADD INFO REC'D 06/28/2022: "THE PORT PLACEMENT WAS ON (B)(6) 2022. THE PORT WAS ACCESSED ON (B)(6) 2022 AND DE-ACCESSED SAME DAY. "

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15004911 ↗
• MalfunctionMar 7, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED "WE HAVE HAD A FEW CASES LATELY BEING REPORTED THAT THE HUBER NEEDLES ARE CRACKING AT THE HUB AGAIN." NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11426780 ↗
• MalfunctionOct 30, 2020Backflow; Fluid/Blood Leak

  IT WAS REPORTED THE CONNECTIONS STARTED ALLOWING BACKFLOW OF BLOOD WHICH THEN STARTED LEAKING OUT OF THE HUB. ALL CONNECTIONS WERE CONNECTED AND SECURE. IT WAS STATED THIS HAPPENED ON TWO OCCASIONS, ONE OF THESE OCCURRENCES HAPPENING DURING A CONTINUING MTX INFUSION. THIS REPORT ADDRESSES THE EVENT DURING MTX INFUSION WITH THE FIRST DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10765694 ↗
• MalfunctionOct 30, 2020Backflow; Fluid/Blood Leak

  IT WAS REPORTED THE CONNECTIONS STARTED ALLOWING BACKFLOW OF BLOOD WHICH THEN STARTED LEAKING OUT OF THE HUB. ALL CONNECTIONS WERE CONNECTED AND SECURE. IT WAS STATED THIS HAPPENED ON TWO OCCASIONS, ONE OF THESE OCCURRENCES HAPPENING DURING A CONTINUING MTX INFUSION. THIS REPORT ADDRESSES THE SECOND DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10765615 ↗
• MalfunctionOct 30, 2020Crack; Leak/Splash

  IT WAS REPORTED "LAST NIGHT, THE CONNECTIONS STARTED ALLOWING BACKFLOW OF BLOOD WITH CHEMO IN A ROOM, WHICH THEN STARTED LEAKING OUT OF THE HUB. ALL CONNECTIONS WERE CONNECTED AND SECURE. WE DID NOT RE-ACCESS WITH THE SAME NEEDLE TYPE BUT USED A REGULAR NEEDLE ON THE POWERPOINT, ACCEPTING THE LIMITATIONS FOR CONTRAST." "PICU IS LOOKING INTO A POTENTIAL FOR CRACKED TUBING YESTERDAY ON HB."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10765547 ↗
• MalfunctionJun 4, 2020Crack; Crack

  IT WAS REPORTED "DURING IV FLUSH CONNECTOR WAS CRACKED AND LEAKING." NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10118451 ↗
• MalfunctionJun 4, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED "DURING A IV FLUSH WHITE CAP FLEW OFF AND SPRAYED SALINE OUT." NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10118446 ↗
• MalfunctionJun 4, 2020Crack; Crack

  IT WAS REPORTED "DURING DRESSING CHANGE CONNECTOR PORT WAS CRACKED AND LEAKING." NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10118440 ↗
• MalfunctionMay 29, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED "WHITE CAP FLEW OFF " OF THE NEEDLE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10102224 ↗
• MalfunctionMay 28, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THE NEEDLE PORT CRACKED AND WAS LEAKING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10096346 ↗
• MalfunctionMar 25, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED VIA MEDWATCH "WHILE ADMINISTERING THROUGH THE PORT, LEAKAGE WAS NOTICED AT LOWER PORT OF THE HUBER NEEDLE LINE. THE CLAVE WAS CHANGED BUT THERE WAS STILL LEAKAGE. UPON CLOSER INSPECTION, A CRACK WAS NOTICED IN THE LOWER PORT OF THE HUBER NEEDLE SET. NO LOT NUMBER AVAILABLE. NO LEAKAGE PRIOR TO THIS ADMINISTRATION. CRACK IN PLASTIC OF LOWER POWER."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9878947 ↗