Port Access Needle 2206220Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00801741065897), received between Jul 10, 2018 and Oct 27, 2022 — classified as 17 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (12 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.

• MalfunctionOct 27, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE PORT NEEDLE HUB LEAKED. THE CUSTOMER IS USING A NEEDLELESS INJECTION CAP WITH THE PORT NEEDLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15686413 ↗
• MalfunctionOct 26, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE PORT NEEDLE HUB LEAKED AT THE CONNECTION WITH THE IV TUBING SET. A NEEDLE-FREE CONNECTOR WAS APPLIED TO THE WINGED INFUSION SET AND THEN CONNECTED TO THE IV TUBING SET AND THERE WAS NO MORE LEAKAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15677400 ↗
• MalfunctionOct 12, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED LEAKAGE HAPPENED WITH WINGED INFUSION SET. WHEN THE NURSE CONNECTED THE IV SET TUBE WITH THE PORT OF THE WINGED INFUSION SET IT SHOWS SOME LEAKAGE FROM THAT CONNECTION. SHE APPLIED THE NEEDLE FREE CONNECTOR AND THEN CONNECTED THE IV SET WITH WINGED INFUSION SET THEN THEY DON'T FIND ANY PROBLEM OF LEAKAGE. PATIENT STATUS / INTERVENTION: NO INTERVENTION REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15589373 ↗
• MalfunctionJul 19, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THERE WAS A SOLUTION LEAK WHEN INSERTING THE PORT NEEDLE (LEAK). ADDITIONAL INFORMATION: THE PATIENTS WHO ARE HOSPITALIZED IN THE ONCOLOGY AREA WITNESSED THE EVENT AND THE NURSES REPORT THAT THEY DID NOT PASS ANY OTHER MEDICATION THAT COULD CAUSE GREATER DAMAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15054929 ↗
• MalfunctionJul 18, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THERE HAVE BEEN AT LEAST 4 EVENTS WHERE THE NEEDLE DETACHES FROM THE WINGS WHEN PUNCTURING THE PORT CATHETER. ADDITIONAL INFORMATION: THE PATIENTS WHO ARE HOSPITALIZED IN THE ONCOLOGY AREA WITNESSED THE EVENT AND THE NURSES REPORT THAT THEY DID NOT PASS ANY OTHER MEDICATION THAT COULD CAUSE GREATER DAMAGE. THIS REPORT ADDRESSES THE FOURTH DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15041855 ↗
• MalfunctionJul 18, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THERE HAVE BEEN AT LEAST 4 EVENTS WHERE THE NEEDLE DETACHES FROM THE WINGS WHEN PUNCTURING THE PORT CATHETER. ADDITIONAL INFORMATION: THE PATIENTS WHO ARE HOSPITALIZED IN THE ONCOLOGY AREA WITNESSED THE EVENT AND THE NURSES REPORT THAT THEY DID NOT PASS ANY OTHER MEDICATION THAT COULD CAUSE GREATER DAMAGE. THIS REPORT ADDRESSES THE SECOND DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15041755 ↗
• MalfunctionJul 18, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THERE HAVE BEEN AT LEAST 4 EVENTS WHERE THE NEEDLE DETACHES FROM THE WINGS WHEN PUNCTURING THE PORT CATHETER. ADDITIONAL INFORMATION: THE PATIENTS WHO ARE HOSPITALIZED IN THE ONCOLOGY AREA WITNESSED THE EVENT AND THE NURSES REPORT THAT THEY DID NOT PASS ANY OTHER MEDICATION THAT COULD CAUSE GREATER DAMAGE. THIS REPORT ADDRESSES THE THIRD DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15041734 ↗
• MalfunctionJul 18, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THERE HAVE BEEN AT LEAST 4 EVENTS WHERE THE NEEDLE DETACHES FROM THE WINGS WHEN PUNCTURING THE PORT CATHETER. ADDITIONAL INFORMATION: THE PATIENTS WHO ARE HOSPITALIZED IN THE ONCOLOGY AREA WITNESSED THE EVENT AND THE NURSES REPORT THAT THEY DID NOT PASS ANY OTHER MEDICATION THAT COULD CAUSE GREATER DAMAGE. THIS REPORT ADDRESSES THE FIRST DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15041711 ↗
• MalfunctionJul 15, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THE PRODUCT PRESENTS A LEAK BETWEEN THE NEEDLE AND THE EXTENSION THAT CONNECTS TO THE INFUSION SET, WHICH IS WHY THE PATIENT HAD TO BE PUNCTURED AGAIN SINCE AN ERYTHROCYTE CONCENTRATE WAS BEING TRANSFUSED. ADDITIONAL INFORMATION RECEIVED BY THE CLIENT ON 02.JUL.2022: WAS THE PATIENT ABLE TO PUNCTURE TO COMPLETE HIS TREATMENT? A: IT WAS PUNCTURED BUT IT COULD NOT BE FINISHED APPLYING IT. HAS THERE BEEN EXPOSURE TO BLOOD OR CHEMOTHERAPY TO THE MUCOUS MEMBRANES OR THE SKIN OF THE PROFESSIONAL OR THE PATIENT? A: YES. THERE WAS NO PATIENT HARM OR NEED FOR MEDICAL INTERVENTION. THE IMPACT WAS THAT IT IS NOT POSSIBLE TO FULLY ADMINISTER THE DRUG AND THAT THERE IS ALSO AN INCREASE IN COSTS FOR THE INSTITUTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15028639 ↗
• MalfunctionJul 14, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY NURSE ¿NEEDLE IS PLACED IN THE PORT CATHETER, CHEMOTHERAPY IS ADMINISTERED AND AN INFUSER IS PLACED FOR CONTINUOUS TREATMENT AT HOME FOR 16 HOURS. HOWEVER, YESTERDAY, (B)(6) 2022, THE PATIENT ATTENDED HER SECOND DAY OF TREATMENT, THE NEEDLE BECAME PERMEABLE AND THE MEDICATION INDICATED IN THE SERVICE WAS ADMINISTERED WITHOUT SETBACKS. AT 11:30 AM, AN INFUSER IS PLACED AGAIN FOR CONTINUOUS TREATMENT AT HOME. AT 9:40 P.M., A CALL WAS RECEIVED FROM THE TREATING PHYSICIAN AND HE REPORTED THAT THE PATIENT NEEDED TO GO TO THE SERVICE AGAIN BECAUSE APPARENTLY THERE WAS A LEAK IN THE INFUSER. THE PATIENT WAS RE-ADMITTED AT 10:20 P.M. AND A REVIEW OF THE LINES AND CONNECTIONS REVEALED THAT THERE WAS INDEED A LEAK FROM THE CONNECTION OF THE SET WITH THE INFUSER. THE PATIENT REPORTS THAT IT WAS AROUND 7:00 P.M. WHEN SHE BEGAN TO LEAK MEDICATION. SHE CHANGES FOR A NEW SET AND RE-INSERTS THE INFUSER, SHE RETURNS TO HER HOME.¿

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15021512 ↗
• MalfunctionSep 10, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AT THE POINT OF ATTACHMENT AT PORT NEEDLE AND DOSIFIX/SAFESET ,THERE WAS LEAK OBSERVED OF FLUID. PATIENT COMPLETED THERAPY USING 2ND NEEDLE. IT WAS REPORTED THIS OCCURRED WITH TWO DEVICES. THIS REPORT ADDRESSES THE FIRST DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12455198 ↗
• MalfunctionSep 10, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AT THE POINT OF ATTACHMENT AT PORT NEEDLE AND DOSIFIX/SAFESET, THERE WAS LEAK OBSERVED OF FLUID. PATIENT COMPLETED THERAPY USING 2ND NEEDLE. IT WAS REPORTED THIS OCCURRED WITH TWO DEVICES. THIS REPORT ADDRESSES THE SECOND DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12455187 ↗
• MalfunctionJul 28, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A NURSE NOTED A LEAK IN THE WIS NEEDLE ATTACHED ON TO A PATIENT'S CHEMO PORT. THE FAULTY PRODUCT WAN NOT USED FURTHER AND A NEW ONE WAS USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12242884 ↗
• MalfunctionFeb 26, 2021Fluid/Blood Leak

  IT WAS REPORTED BY FACILITY PHARMACY THAT THE WINGED INFUSION SET NEEDLE LEAKED FROM THE CONNECTION SITE. THE DR. STATED THE PATIENT WAS RECEIVING CHEMO AND WAS DISCHARGED FROM THE FACILITY. NO OTHER DETAILS ARE AVAILABLE AND DEVICE WAS DISCARDED AFTER THE EVENT.

  MAUDE report 11386481 ↗
• MalfunctionFeb 26, 2021Fluid/Blood Leak

  IT WAS REPORTED BY FACILITY PHARMACY THAT THE WINGED INFUSION SET NEEDLE LEAKED FROM THE CONNECTION SITE. THE DR. STATED THE PATIENT WAS RECEIVING CHEMO AND WAS DISCHARGED FROM THE FACILITY. NO OTHER DETAILS ARE AVAILABLE AND DEVICE WAS DISCARDED AFTER THE EVENT.

  MAUDE report 11386444 ↗
• MalfunctionMay 14, 2019Break; Leak/Splash

  IT WAS REPORTED THAT DURING THE USE WINGED INFUSION SET THEY FOUND THAT THE BLUE COLORED TUBE CONNECTED TO 3 WAY STOPCOK WAS BROKEN HENCE LEAKAGE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8607467 ↗
• MalfunctionJul 10, 2018Fluid/Blood Leak; Flushing Problem

  IT WAS REPORTED THAT BEFORE USING THE PORT NEEDLE THE DOCTOR FLUSHED THE NEEDLE AND FOUND THAT THERE WAS A LEAKAGE ON THE TUBING. THE DEVICE WAS NOT USED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7675927 ↗