Port Access Needle 0604190Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00801741065804), received between Aug 31, 2018 and Mar 2, 2022 — classified as 17 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (6 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 2, 2022Crack; Crack

  IT WAS REPORTED "CRACKED AT THE CONNECTION SITE. HAD TO DEACCESS AND REACCESS PORT." ADDITIONAL INFO. RECEIVED (B)(6) 2022: WAS THE PRODUCT USED ON A PATIENT? YES WAS THERE ANY PATIENT HARM REPORTED? NO WHAT THEY¿RE BEING TREATED FOR: CANCER DIAGNOSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13656204 ↗
• MalfunctionJan 7, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED PATIENT CONTACTED NURSING TEAM TO ADVISE THEM THAT HER PORTACATH NEEDLE LINE HAD FRACTURED. NURSING TEAM ADVISED PATIENT TO CLAMP THE LINE ABOVE WHERE THE FRACTURE WAS LOCATED TO ENSURE THAT NOTHING WAS ABLE TO ENTER THE LINE. PATIENT BOOKED TO ATTEND FACILITY ON THE SAME DAY AND THE PORT NEEDLE WAS REMOVED. PATIENT REVIEWED BY THE MEDICAL TEAM. PATIENT'S PORTACATH WAS RE-ACCESSED SAFELY, AND THEIR IV ANTIBIOTIC TREATMENT HAS RESUMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13191821 ↗
• MalfunctionNov 24, 2021Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED, "THE NEEDLES CAME DAMAGED, SOME OF THEM WERE DUSTY AND THE TWO OF THEM CAME IN DAMAGED BOX, SO THEY ARE NOT STERILE ANYMORE." THIS REPORT ADDRESSES THE SECOND OF THE TWO NEEDLES THAT WERE DAMAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12870276 ↗
• MalfunctionNov 24, 2021Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED, "THE NEEDLES CAME DAMAGED, SOME OF THEM WERE DUSTY AND THE TWO OF THEM CAME IN DAMAGED BOX, SO THEY ARE NOT STERILE ANYMORE." THIS REPORT ADDRESSES THE FIRST OF THE TWO NEEDLES THAT WERE DAMAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12870251 ↗
• MalfunctionJun 11, 2019Leak/Splash

  IT WAS REPORTED THAT THE WINGED INFUSION SET WAS LEAKING BY THE YELLOW PIECE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8689159 ↗
• MalfunctionOct 4, 2018Fracture

  IT WAS REPORTED THAT THE INFUSION SET WAS FRACTURED. THE INFUSION WAS STOPPED AND THE INFUSION SET WAS REMOVED. NO REPORTED PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7936879 ↗
• MalfunctionSep 24, 2018Material Split, Cut or Torn

  IT WAS REPORTED THAT THE FACILITY HAD THREE WINGED INFUSION SETS IN WHICH LINES SPLIT. THIS REPORT ADDRESSES THE THIRD DEVICE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7903771 ↗
• MalfunctionSep 24, 2018Material Split, Cut or Torn

  IT WAS REPORTED THAT THE FACILITY HAD THREE WINGED INFUSION SETS IN WHICH LINES SPLIT. THIS REPORT ADDRESSES THE SECOND DEVICE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7903766 ↗
• MalfunctionSep 21, 2018Material Split, Cut or Torn

  IT WAS REPORTED THAT THE FACILITY HAD THREE WINGED INFUSION SETS IN WHICH LINES SPLIT. THIS REPORT ADDRESSES THE FIRST DEVICE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7899759 ↗
• MalfunctionAug 31, 2018Leak/Splash

  IT WAS REPORTED THAT LEAKAGE WAS NOTICED EIGHT TIMES ON THE NEEDLE/EXTENSION SET DURING ADMINISTRATION OF CHEMOTHERAPY (2X CARBOPLATINUM), DURING INFUSION OR DRIPPING OF NACL 0.9%, OR INJECTION OF MEDICATION WITH SYRINGE (LIKE LICITAN). THIS REPORT ADDRESSES THE EIGHTH EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7838224 ↗
• MalfunctionAug 31, 2018Fluid/Blood Leak

  IT WAS REPORTED THAT LEAKAGE WAS NOTICED EIGHT TIMES ON THE NEEDLE/EXTENSION SET DURING ADMINISTRATION OF CHEMOTHERAPY (2X CARBOPLATINUM), DURING INFUSION OR DRIPPING OF NACL 0.9%, OR INJECTION OF MEDICATION WITH SYRINGE (LIKE LICITAN). THIS REPORT ADDRESSES THE SIXTH EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7838223 ↗
• MalfunctionAug 31, 2018Leak/Splash

  IT WAS REPORTED THAT LEAKAGE WAS NOTICED EIGHT TIMES ON THE NEEDLE/EXTENSION SET DURING ADMINISTRATION OF CHEMOTHERAPY (2X CARBOPLATINUM), DURING INFUSION OR DRIPPING OF NACL 0.9%, OR INJECTION OF MEDICATION WITH SYRINGE (LIKE LICITAN). THIS REPORT ADDRESSES THE SEVENTH EVENT.

  Patient problems: No Information

  MAUDE report 7838222 ↗
• MalfunctionAug 31, 2018Fluid/Blood Leak

  IT WAS REPORTED THAT LEAKAGE WAS NOTICED EIGHT TIMES ON THE NEEDLE/EXTENSION SET DURING ADMINISTRATION OF CHEMOTHERAPY (2X CARBOPLATINUM), DURING INFUSION OR DRIPPING OF NACL 0.9%, OR INJECTION OF MEDICATION WITH SYRINGE (LIKE LICITAN). THIS REPORT ADDRESSES THE THIRD EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7838219 ↗
• MalfunctionAug 31, 2018Fluid/Blood Leak

  IT WAS REPORTED THAT LEAKAGE WAS NOTICED EIGHT TIMES ON THE NEEDLE/EXTENSION SET DURING ADMINISTRATION OF CHEMOTHERAPY (2X CARBOPLATINUM), DURING INFUSION OR DRIPPING OF NACL 0.9%, OR INJECTION OF MEDICATION WITH SYRINGE (LIKE LICITAN). THIS REPORT ADDRESSES THE FIFTH EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7838215 ↗
• MalfunctionAug 31, 2018Leak/Splash

  IT WAS REPORTED THAT LEAKAGE WAS NOTICED EIGHT TIMES ON THE NEEDLE/EXTENSION SET DURING ADMINISTRATION OF CHEMOTHERAPY (2X CARBOPLATINUM), DURING INFUSION OR DRIPPING OF NACL 0.9%, OR INJECTION OF MEDICATION WITH SYRINGE (LIKE LICITAN). THIS REPORT ADDRESSES THE SECOND EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7838214 ↗
• MalfunctionAug 31, 2018Fluid/Blood Leak

  IT WAS REPORTED THAT LEAKAGE WAS NOTICED EIGHT TIMES ON THE NEEDLE/EXTENSION SET DURING ADMINISTRATION OF CHEMOTHERAPY (2X CARBOPLATINUM), DURING INFUSION OR DRIPPING OF NACL 0.9%, OR INJECTION OF MEDICATION WITH SYRINGE (LIKE LICITAN). THIS REPORT ADDRESSES THE FOURTH EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7838211 ↗
• MalfunctionAug 31, 2018Fluid/Blood Leak

  IT WAS REPORTED THAT LEAKAGE WAS NOTICED EIGHT TIMES ON THE NEEDLE/EXTENSION SET DURING ADMINISTRATION OF CHEMOTHERAPY (2X CARBOPLATINUM), DURING INFUSION OR DRIPPING OF NACL 0.9%, OR INJECTION OF MEDICATION WITH SYRINGE (LIKE LICITAN). THIS REPORT ADDRESSES THE FIRST EVENT.

  Patient problems: No Information

  MAUDE report 7838203 ↗