Port Access Kit PA-0031YNRecalls & reported problems
Bard Access Systems, Inc. · Port Access Kit SafeStep 20G x 0.75 inch with y-site · Class 2
All models of Port Access Kit (49)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00801741085536), received between Jun 9, 2022 and Sep 15, 2026 — classified as 7 malfunctions.
The most frequently reported specific device problem is “Loss of or Failure to Bond” (3 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 18, 2026.
Reports received per month
Recalls naming this device
- Jun 19, 2020Class IITerminated
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-2666-2020 · Root cause: Process control · Recall details · FDA record ↗
Most reported problems
Device problems
- Loss of or Failure to Bond3
- Fluid/Blood Leak2
- Activation Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions6
- Unintended Loss of Vascular Access1
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 15, 2026Activation Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50776470 ↗MalfunctionApr 23, 2026Loss of or Failure to Bond
IT WAS REPORTED BY CUSTOMER THAT DRESSING IN THE KIT IS NOT ADHERING TO THE PATIENTS RIGHT AFTER APPLICATION. NO FURTHER DETAILS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24966307 ↗MalfunctionApr 17, 2025Loss of or Failure to Bond; Loss of or Failure to Bond
IT WAS REPORTED, TEGADERM DRESSING IN PAK'S IS NOT STICKING TO THE PATIENT. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21860550 ↗MalfunctionApr 17, 2025Loss of or Failure to Bond; Loss of or Failure to Bond
IT WAS REPORTED, TEGADERM DRESSING IN PAK'S IS NOT STICKING TO THE PATIENT. THE DRESSING CAME OFF AND NEEDLE CAME OUT. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: Unintended Loss of Vascular Access
MAUDE report 21860107 ↗MalfunctionSep 6, 2023Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED BY MEDWATCH THAT LEAKING OF SALINE NOTED JUST ABOVE CLAVE CAP DURING FLASH AND TUBING AT THIS LEVEL NOTED TO BE CRACKED/LEAKING. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17695951 ↗MalfunctionAug 21, 2023
ATTEMPTED TO FLUSH PORT; LEAKING OF SALINE NOTED JUST ABOVE CLAVE CAP DURING FLUSH, AND TUBING AT THIS LEVEL NOTED TO BE CRACKED/LEAKING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17583748 ↗MalfunctionJun 9, 2022Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED VIA MEDWATCH: "WHEN ASPIRATING FOR LAB DRAW FROM DISTAL CLAVE, THERE WERE AIR BUBBLES IN THE TUBING. HAD TO USE PROXIMAL CLAVE TO DRAW BLOOD FROM HUBER NEEDLE. THE LOT AND EXPIRATION ARE FROM THE PORT ACCESS KIT IN WHICH THE NEEDLE RESIDES." ADD INFO RCVD: 05/23/2022: WAS THE AIR BUBBLES ASSOCIATED WITH A LEAKAGE? NO. WERE THERE ANY ADVERSE EVENTS ASSOCIATED WITH THE AIR BUBBLES? NO. WAS MEDICAL TREATMENT PROVIDED AND IF SO, WHAT WAS DONE? USED PROXIMAL CLAVE. WAS THE PRODUCT USED ON A PATIENT? YES WAS THERE ANY PATIENT HARM REPORTED? IF YES, PLEASE DESCRIBE THE HARM, HOW IT WAS TREATED AND THE OUTCOME. NO HARM TO PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14650889 ↗
Other Set, administration, intravascular devices
- Autosoft XC 1001680Unomedical A/S · Set, Administration, Intravascular1 death16,105 reports
- Autosoft90™ 1002817Unomedical A/S · Set, Administration, Intravascular1 recall11,907 reports
- Minimed™ Quick-set™ MMT-399AUnomedical A/S · Set, Administration, Intravascular9 deaths8,669 reports
- Medtronic Extended MMT-431AUnomedical A/S · Set, Administration, Intravascular3 deaths8,574 reports
- MiniMed™ Mio™ Advance MMT-242AUnomedical A/S · Set, Administration, Intravascular15 deaths8,164 reports
- CADD 21-7302-24Icu Medical, Inc. · Set, administration, intravascular4 recalls1 death4,657 reports
- Autosoft XC 1001681Unomedical A/S · Set, Administration, Intravascular1 death4,216 reports
- Minimed™ Quick-set™ MMT-397AUnomedical A/S · Set, Administration, Intravascular19 deaths4,134 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page