Port Access Needle 0681934Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00801741048005), received between Jan 22, 2019 and Mar 18, 2026 — classified as 1 injury, 14 malfunctions.

The most frequently reported specific device problem is “Activation Problem” (5 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjuryMar 18, 2026Activation Problem

  IT WAS REPORTED THAT PATIENT DOES HER OWN SELF DISCONNECT FROM HER PORT AT HOME. PATIENT HANDED WRITER THE BAG WITH OLD PORT DEVICE AND CHEMO BOTTLE. WHEN WRITER TOOK BAG NEEDLE POKED THROUGH BAG AND POKED WRITERS FINGER CAUSING FINGER TO BLEED. NO FURTHER DETAILS PROVIDED.

  Patient problems: Exposure to Body Fluids; Needle Stick/Puncture

  MAUDE report 24634758 ↗
• MalfunctionMar 18, 2026Activation Problem

  IT WAS REPORTED THAT PATIENT STATED SHE HAS POKED HERSELF SEVERAL TIMES AS THE DEVICE HAS NEVER ONCE LOCKED INTO THE SAFETY POSITION. PATIENT STATES SHE HAS BEEN DOING HER OWN DISCONNECTS FOR A YEAR. NO FURTHER DETAILS PROVIDED. A SPECIFIC NUMBER OF AFFECTED DEVICES WAS NOT PROVIDED BY THE COMPLAINANT.

  Patient problems: Needle Stick/Puncture

  MAUDE report 24630424 ↗
• MalfunctionSep 11, 2020Activation Problem; Activation Problem

  IT WAS REPORTED THAT THERE WERE TWO NEEDLE STICK INJURIES. IT WAS STATED WHEN THE NEEDLE IS PULLED AND SECURED BACK INTO THE SAFETY LOCK, SOMETIMES THE TIP WILL NOT COMPLETELY RETRACT INTO THE DEVICE (EVEN THOUGH IT¿S LOCK). THE NURSES HAVE STUCK THEMSELVES BECAUSE THEY ASSUME THE NEEDLE HAS BEEN COMPLETELY COVERED. IT WAS FURTHER REPORTED THAT THREE NURSES HAVE HAD NEEDLE STICKS, TWO OF WHICH COMPLETED BLOODWORK THEMSELVES AND ALSO HAD THE PATIENT¿S BLOOD TESTED FOR COMMUNICABLE DISEASES. ONE NURSE DECLINED BLOODWORK FOR HER OR THE PATIENT AND DECLINED REPORTING THE EVENT. THIS REPORT ADDRESSES THE THIRD NEEDLE STICK AND THE NURSE WHO DECLINED BLOODWORK.

  Patient problems: Exposure to Body Fluids; Needle Stick/Puncture

  MAUDE report 10522442 ↗
• MalfunctionSep 11, 2020Activation Problem; Activation Problem

  IT WAS REPORTED THAT THERE WERE TWO NEEDLE STICK INJURIES. IT WAS STATED WHEN THE NEEDLE IS PULLED AND SECURED BACK INTO THE SAFETY LOCK, SOMETIMES THE TIP WILL NOT COMPLETELY RETRACT INTO THE DEVICE (EVEN THOUGH IT¿S LOCK). THE NURSES HAVE STUCK THEMSELVES BECAUSE THEY ASSUME THE NEEDLE HAS BEEN COMPLETELY COVERED. IT WAS FURTHER REPORTED THAT THREE NURSES HAVE HAD NEEDLE STICKS, TWO OF WHICH COMPLETED BLOODWORK THEMSELVES AND ALSO HAD THE PATIENT¿S BLOOD TESTED FOR COMMUNICABLE DISEASES. ONE NURSE DECLINED BLOODWORK FOR HER OR THE PATIENT AND DECLINED REPORTING THE EVENT. THIS REPORT ADDRESSES THE SECOND NEEDLE STICK AND THE SECOND OF THE TWO NURSES WHO DID BLOODWORK.

  Patient problems: Exposure to Body Fluids; Needle Stick/Puncture

  MAUDE report 10522441 ↗
• MalfunctionSep 11, 2020Activation Problem; Activation Problem

  IT WAS REPORTED THAT THERE WERE TWO NEEDLE STICK INJURIES. IT WAS STATED WHEN THE NEEDLE IS PULLED AND SECURED BACK INTO THE SAFETY LOCK, SOMETIMES THE TIP WILL NOT COMPLETELY RETRACT INTO THE DEVICE (EVEN THOUGH IT¿S LOCK). THE NURSES HAVE STUCK THEMSELVES BECAUSE THEY ASSUME THE NEEDLE HAS BEEN COMPLETELY COVERED. IT WAS FURTHER REPORTED THAT THREE NURSES HAVE HAD NEEDLE STICKS, TWO OF WHICH COMPLETED BLOODWORK THEMSELVES AND ALSO HAD THE PATIENT¿S BLOOD TESTED FOR COMMUNICABLE DISEASES. ONE NURSE DECLINED BLOODWORK FOR HER OR THE PATIENT AND DECLINED REPORTING THE EVENT. THIS REPORT ADDRESSES THE FIRST NEEDLE STICK AND ONE OF THE TWO NURSES WHO DID BLOODWORK.

  Patient problems: Exposure to Body Fluids; Needle Stick/Puncture

  MAUDE report 10522431 ↗
• MalfunctionSep 11, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THERE HAVE BEEN 3 PATIENTS WITH A BAXTER INFUSOR (¿BABY BOTTLE¿) WHERE THE DRUG WAS NOT COMPLETELY INFUSED WITHIN THE 46 HOURS ADMINISTRATION TIME. THEY ARE WORRIED THAT THE PORT NEEDLES ARE BECOMING SLIGHTLY DISLODGED AND AFFECTING THE INFUSION RATE. THIS REPORT ADDRESSES THE FIRST DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10522314 ↗
• MalfunctionSep 11, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THERE HAVE BEEN 3 PATIENTS WITH A BAXTER INFUSOR (¿BABY BOTTLE¿) WHERE THE DRUG WAS NOT COMPLETELY INFUSED WITHIN THE 46 HOURS ADMINISTRATION TIME. THEY ARE WORRIED THAT THE PORT NEEDLES ARE BECOMING SLIGHTLY DISLODGED AND AFFECTING THE INFUSION RATE. THIS REPORT ADDRESSES THE SECOND DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10522304 ↗
• MalfunctionSep 11, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THERE HAVE BEEN 3 PATIENTS WITH A BAXTER INFUSOR (¿BABY BOTTLE¿) WHERE THE DRUG WAS NOT COMPLETELY INFUSED WITHIN THE 46 HOURS ADMINISTRATION TIME. THEY ARE WORRIED THAT THE PORT NEEDLES ARE BECOMING SLIGHTLY DISLODGED AND AFFECTING THE INFUSION RATE. THIS REPORT ADDRESSES THE THIRD DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10522275 ↗
• MalfunctionSep 10, 2020Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  IT WAS REPORTED "PATIENT WAS ACCESSED AND EXPERIENCED LEAKING AT THE Y-SITE." NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10518127 ↗
• MalfunctionMar 18, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY THE FACILITY THAT "THE PORT NEEDLES CHANGED. I WAS ABLE TO OBTAIN A NEW AND OLD PORT NEEDLE. THE DIFFERENCE IS THE OLD PORT NEEDLES HAD BLUE CAPS AND WHITE CLIPS. THEY WERE MADE IN MEXICO. THE NEW NEEDLES HAVE WHITE CAPS AND CLEAR CLIPS AND ARE MADE IN CHINA. NOW THAT THE NEWER NEEDLES ARE MAKING THERE WAYS INTO ALL OF THE AHS INFUSION CENTERS WE ARE SEEING MORE AND MORE CRACKS."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9848692 ↗
• MalfunctionJan 22, 2019Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING CHEMOTHERAPY INFUSION, THE BLUE CAP POPPED OFF. NO PATIENT HARM WAS REPORTED. IT WAS STATED THIS HAPPENED WITH FIVE DEVICES. THIS REPORT ADDRESSES THE SECOND DEVICE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8269472 ↗
• MalfunctionJan 22, 2019Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING CHEMOTHERAPY INFUSION, THE BLUE CAP POPPED OFF. NO PATIENT HARM WAS REPORTED. IT WAS STATED THIS HAPPENED WITH FIVE DEVICES. THIS REPORT ADDRESSES THE FIFTH DEVICE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8269469 ↗
• MalfunctionJan 22, 2019Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING CHEMOTHERAPY INFUSION, THE BLUE CAP POPPED OFF. NO PATIENT HARM WAS REPORTED. IT WAS STATED THIS HAPPENED WITH FIVE DEVICES. THIS REPORT ADDRESSES THE THIRD DEVICE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8269458 ↗
• MalfunctionJan 22, 2019Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING CHEMOTHERAPY INFUSION, THE BLUE CAP POPPED OFF. NO PATIENT HARM WAS REPORTED. IT WAS STATED THIS HAPPENED WITH FIVE DEVICES. THIS REPORT ADDRESSES THE FIRST DEVICE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8269422 ↗
• MalfunctionJan 22, 2019Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING CHEMOTHERAPY INFUSION, THE BLUE CAP POPPED OFF. NO PATIENT HARM WAS REPORTED. IT WAS STATED THIS HAPPENED WITH FIVE DEVICES. THIS REPORT ADDRESSES THE FOURTH DEVICE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8269339 ↗