First PICC™ S/L Peripherally Inserted Central Catheter 384101Recalls & reported problems
Argon Medical Devices, Inc. · First PICC™ S/L Peripherally Inserted Central Catheter 22ga (2.8F) 0.95mm x 50cm · Class 2 · Implant
All models of First PICC S/L Peripherally Inserted Central Catheter (5)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 8
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00886333209644), received between Dec 18, 2020 and Dec 8, 2024 — classified as 8 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (3 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Fluid/Blood Leak3
- Break2
- Collapse1
- Crack1
- Difficult to Advance1
- Difficult to Remove1
- Insufficient Device Problem Information1
- Leak/Splash1
Patient problems
- Insufficient Information4
- No Clinical Signs, Symptoms or Conditions4
- Discomfort1
Recent adverse event reports
The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 8, 2024Leak/Splash; Leak/Splash
THE CATHETER HAS A LEAK IN THE HOSE WHERE IT DRIPS WHEN INFUSING LIQUID.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20875370 ↗MalfunctionFeb 28, 2023Crack; Crack
WE HAD ANOTHER ARGON PICC MADE BY ARGON RUPTURE. IT WAS A 2.8F SINGLE LUMEN. LOT# 11405481.¿
Patient problems: Discomfort; No Clinical Signs, Symptoms or Conditions
MAUDE report 16454174 ↗MalfunctionSep 12, 2022Break; Fluid/Blood Leak
WE HAVE A 2.8FR NON POWER ARGON SINGLE LUMEN PICC THAT BROKE ON 8/12/22. IT WAS PLACED ON 7/26/22. I CAN PROVIDE MORE DETAILS TO THE CORRECT PERSON/DEPARTMENT.¿ SENT EMAIL TO LANA 8/30/2022 REQUESTING ADDITIONAL INFORMATION ¿ AWAITING RESPONSE SENT EMAIL TO LANA 9/2/2022 REQUESTING ADDITIONAL INFORMATION ¿ AWAITING RESPONSE UPDATE AS OF 9/2/2022 @ 1709- PER LANA ¿THE PICC WAS LEAKING, TOOK DOWN DRESSING, PICC BROKE, & ESTIMATED BLOOD LOSS 1-2CC¿.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15403452 ↗MalfunctionAug 18, 2022Difficult to Remove; Physical Resistance/Sticking
"WHEN TRYING TO REMOVE THE GUIDE WIRE, AFTER PASSING THE CATHETER AND CHECKING THE X-RAY, IT PRESENTS RESISTANCE TO REMOVAL, PULLING THE PICC CATHETER ALONG WITH IT. MANEUVERS ARE PERFORMED FOR ITS REMOVAL"
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15248999 ↗MalfunctionAug 9, 2022Break; Collapse; Difficult to Advance; Mechanical Jam
ON JUNE 8TH , A PICC CATHETER WAS INSERTED IN A CHILD ADMITTED TO THE PEDIATRIC INTENSIVE CARE UNIT, THE CATHETER WAS LUBRICATED ACCORDING TO ROUTINE, THE MANDREL WAS PULLED 3CM FOR INTRODUCTION, THE CATHETER PROGRESSED EASILY, WITH GOOD FLOW AND REFLUX, HOWEVER, AT THE MOMENT OF TOTAL TRACTION OF THE MANDREL, IT DID NOT COME OUT, GETTING STUCK TO THE CATHETER, COLLAPSED, BRINGING THE CATHETER OUT. WHEN FORCING THE WITHDRAWAL, IT ENDED UP DAMAGING IT. THIS HAPPENED WITH TWO CATHETERS IN THE SAME PATIENT.. DUE TO THE NEED OF ACCESS, A THIRD CATHETER WAS NECESSARY, IN WHICH I REMOVED THE MANDREL BEFORE INSERTING IT, TO OBTAIN SUCCESS IN THE PROCEDURE. I TAKE THE OPPORTUNITY TO REGISTER THAT THIS SAME EPISODE HAS ALREADY HAPPENED IN THE PASSAGE OF PICC CATHETER IN ADULTS, WITH ME AND WITH MY COLLEAGUES.
Patient problems: Insufficient Information
MAUDE report 15191881 ↗MalfunctionFeb 8, 2022Material Discolored; Fluid/Blood Leak
WHEN OPENING THE CATHETER FOR THE PROCEDURE, THE GUIDE WIRE WAS REMOVED, A 10ML SYRINGE WITH 0.9% SALINE SOLUTION WAS CONNECTED AND THE FLUSH WAS PERFORMED TO FILL THE CATHETER. HOWEVER, I OBSERVED SALINE LEAKAGE AT THE BEGINNING OF THE CATHETER, JUST AFTER THE ROUND TRANSPARENT PART, BEFORE THE ZERO POINT. I ALSO OBSERVED THAT THE CATHETER IS GRAYISH IN COLOR IN THIS AREA.
Patient problems: Insufficient Information
MAUDE report 13480977 ↗MalfunctionAug 18, 2021Fluid/Blood Leak; Material Split, Cut or Torn
WE HAVE BEEN TRIALING THE ARGON FIRST PICC FOR A COUPLE MONTHS NOW WITH OUR NICU PATIENTS. WE CAME ACROSS AN ISSUE WITH ONE WE PLACED IN A BABY ON THE 8TH OF JULY. SORRY FOR THE DELAY IN GETTING INFORMATION OUT TO YOU BUT IT TOOK A LITTLE TIME TO HEAR ABOUT IT GET THE PICC IN HAND. A LINE WAS PLACED IN THE OR IN THE AM OF THE 8TH AND AFTER THE PATIENT WAS BACK UP ON THE FLOOR, THE BEDSIDE RN NOTICED IT WAS LEAKING AT THE INSERTION SITE AND ASKED FOR A LINE EXCHANGE. OUR TEAM WENT UPSTAIRS, AND PERFORMED THE EXCHANGE WITH NO FURTHER ISSUES SINCE THEN. WHEN WE RECEIVED THE LINE FROM THE NICU, I WAS ABLE TO INSPECT THE LINE AND NOTICED THAT THERE WAS A HORIZONTAL TEAR IN THE CATHETER. WE ARE UNAWARE OF ANY ISSUES DURING PLACEMENT BUT I AM THINKING IT MAYBE WIRE INSERTION COULD HAVE PLAYED A ROLE
Patient problems: Insufficient Information
MAUDE report 12338655 ↗MalfunctionDec 18, 2020Insufficient Device Problem Information
Other Catheter,Intravascular,Therapeutic,Short-Term Less Than 30 Days devices
- BD Insyte Autoguard 382523Becton, Dickinson And Company · Catheter,intravascular,therapeutic,short-term less than 30 days660 reports
- BD Insyte Autoguard 382533Becton, Dickinson And Company · Catheter,intravascular,therapeutic,short-term less than 30 days2 recalls527 reports
- BD PosiFlush 306546Becton, Dickinson And Company · Catheter,intravascular,therapeutic,short-term less than 30 days1 death608 reports
- BD Insyte Autoguard Shielded IV Catheter 381823Becton, Dickinson And Company · Catheter, intravascular, therapeutic, short-term less than 30 days582 reports
- BD Insyte Autoguard 381423Becton, Dickinson And Company · Catheter,intravascular,therapeutic,short-term less than 30 days1 recall528 reports
- BD Insyte Autoguard 382544Becton, Dickinson And Company · Catheter,intravascular,therapeutic,short-term less than 30 days1 recall437 reports
- BD Nexiva, BD Q-Syte 383536Becton, Dickinson And Company · Catheter,intravascular,therapeutic,short-term less than 30 days2 recalls374 reports
- BD PosiFlush 306547Becton, Dickinson And Company · Catheter,intravascular,therapeutic,short-term less than 30 days2 recalls1 death331 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
- 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