Port Access Needle 0651934Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00801741047732), received between Oct 14, 2020 and Nov 1, 2023 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Activation Problem” (2 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryNov 1, 2023Activation Problem; Activation Problem

  IT WAS REPORTED BY CUSTOMER THAT THE SAFETY DEVICE ON THE MEDPORT WAS NOT WORKING. SHE STATED SHE "HAD TO GRAB THE 2ND SET OF WINGS TO PULL". STATED SHE HAD HER RIGHT HAND HOLDING THE SKIN TAUGHT AND HER LEFT HAND PULLING UP FROM THE BASE OF THE PORT AND THAT IS WHEN THE NEEDLESTICK OCCURRED. RESPONSE RECEIVED 16 OCT 2023 DID NOT INVOLVE AN URGENT/LIFE THREATENING MEDICAL SITUATION, AND NO PATIENT HARM. IT DID NOT INTERRUPT THE ADMINISTRATION OF ANY MEDICATION, OR CAUSE A CLINICALLY SIGNIFICANT DELAY IN MEDICATION. PATIENT WAS NOT AFFECTED EXCEPT THAT SHE HAD RECEIVE POST EXPOSURE PATIENT TESTING. WHILE DE-ACCESSING THE MED PORT THE NURSE HELD 2 FINGERS ON EACH SIDE OF THE PORT WITH HER LEFT HAND AND ATTEMPTED TO PULL THE NEED OUT WITH HER RIGHT HAND HOLDING ON THE WINGS. THE NEEDLE WOULD NOT RETRACT AND SHE COULD NOT DE-ACCESS THE PORT USING THE WINGS IN THE NORMAL FASHION. AFTER TRYING A COUPLE OF TIMES UNSUCCESSFULLY, SHE HAD TO REMOVE THE NEEDLE BY PULLING IT FROM THE BOTTOM WINGS (BASE). AS SHE PULLED REMOVED IT, THE NEEDLE SCRAPED HER FINGER, RIPPING HER GLOVE CAUSING AN ABRASION TO HER SKIN. ADDT RESPONSE RECEIVED 20 OCT 2023 PATIENT DID NOT HAVE A BLOODBORNE DISEASE. CLINIC

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

  MAUDE report 18052620 ↗
• MalfunctionSep 29, 2022Activation Problem; Activation Problem

  IT WAS REPORTED BY THE CUSTOMER THAT "WE HAD AN INCIDENT LAST WEEK WHERE ONE OF OUR POWER LOC NEEDLES DID NOT FULLY COVER THE NEEDLE WHEN THE SAFETY MECHANISM WAS ENGAGED, AND IT RESULTED IN A NURSE BEING POKED BY THE NEEDLE."

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

  MAUDE report 15506471 ↗
• MalfunctionSep 28, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED "WHEN THE NURSE WAS PRIMING THE NEEDLE NS SOLUTION CAME OUT OF THE NEEDLE HOUSING VERSES THE TIP OF THE NEEDLE. THE NEEDLE WAS NOT USED IN ACCESSING THE PT MEDIPORT AND SENT DOWN TO SUPPLY. NEEDLE SIZE 0.75 INCH."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12542696 ↗
• MalfunctionOct 14, 2020Fluid/Blood Leak; Flushing Problem

  IT WAS REPORTED THAT THE PATIENT CAME IN FOR PORT FLUSH, NURSE WENT TO FLUSH NEEDLE, AND DROP OF SALINE OOZED OUT THE PORT NEEDLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10681002 ↗