First PICC™ S/L Peripherally Inserted Central Catheter 384156Recalls & reported problems
Argon Medical Devices, Inc. · First PICC™ S/L Peripherally Inserted Central Catheter 20ga (3F) 0.95mm x 65cm · 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
- 6
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00886333209675), received between Nov 2, 2020 and Jun 18, 2025 — classified as 1 injury, 5 malfunctions.
The most frequently reported specific device problem is “Break” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Break2
- Fluid/Blood Leak1
- Material Deformation1
- Material Puncture/Hole1
- Physical Resistance/Sticking1
Patient problems
- Insufficient Information3
- Foreign Body In Patient1
- No Clinical Signs, Symptoms or Conditions1
- Thrombosis/Thrombus1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
InjuryJun 18, 2025Break; Break
DURING PLACEMENT OF A PICC, THE PICC BECAME MALPOSITIONED AND "FLIPPED TOWARDS THE SHOULDER." WHEN REPOSITIONING THE PICC WAS ATTEMPTED, THE PICC FRACTURED, AND ONLY 3CM OF THE CATHETER CAME OUT WHEN EXTRACTION WAS ATTEMPTED, LEAVING 28CM IN THE PATIENT. THE PATIENT WAS TAKEN TO THE OPERATING ROOM AND TO THE CATH LAB DUE TO THE THROMBUS, OR THE PORTION THAT REMAINED IN THE BODY, IN THE PULMONARY ARTERY. THIS PORTION OF THE CATHETER WAS EVENTUALLY ABLE TO BE REMOVED AND IS STILL BEING EVALUATED BY PATHOLOGY AT HOSPITAL (AS OF (B)(6)2025). SAMPLE IS AVAILABLE.
Patient problems: Thrombosis/Thrombus
MAUDE report 22285535 ↗MalfunctionAug 22, 2024Material Puncture/Hole; Material Puncture/Hole
REPORTER INDICATED "ATTEMPTED PUNCTURE IN MSD WITH SINGLE PUNCTURE, BUT CATHETER AFTER MIGRATION WHEN REMOVING THE GUIDE WIRE IT SHOWED SIGNIFICANT RESISTANCE, AND WHEN PULLED THE CATHETER CURLED, AS IF IT HAD STUCK. BECAUSE THE EXTENSION HAD CURLED AND WE WERE ABLE TO REMOVE THE GUIDE WIRE COMPLETELY, WHEN WE PERFORMED THE FLUSH, WE FOUND A HOLE IN THE CATHETER NEAR THE CANNON, MAKING IT IMPOSSIBLE TO KEEP THE CATHETER IN THE PATIENT. DEVICE REMOVED AND EMERGENCY PHYSICIAN PERFORMED INTRACATH PASSAGE."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20033883 ↗MalfunctionJun 3, 2024Physical Resistance/Sticking; Physical Resistance/Sticking
ATTEMPTED PUNCTURE IN MSD WITH SINGLE PUNCTURE, BUT CATHETER AFTER MIGRATION WHEN REMOVING THE GUIDE WIRE IT SHOWED SIGNIFICANT RESISTANCE, AND WHEN PULLED THE CATHETER CURLED, AS IF IT HAD "STUCK". BECAUSE THE EXTENSION HAD CURLED UP AND WE WERE ABLE TO REMOVE THE GUIDE WIRE COMPLETELY WHEN FLUSHING, A HOLE WAS FOUND IN THE CATHETER NEAR THE "CANNON", MAKING IT IMPOSSIBLE TO KEEP THE CATHETER IN THE PATIENT. DEVICE REMOVED AND EMERGENCY PHYSICIAN PERFORMED INTRACATH PASSAGE.
Patient problems: Insufficient Information
MAUDE report 19448149 ↗MalfunctionFeb 1, 2023Break; Break
CATHETER 3.0 FR (LOT:11371098 VAL:06/04/2024) AND INTRODUCER #4 (LOT:22.05.117565 VAL:05/30/2025) ARGON BRAND.; E JUGULAR VEIN CHOSEN AND CATHETER CUT AT 16CM; PERFORMED SURGICAL BRUSHING OF THE TEAM WITH CHLORHEXIDINE DEGERMING; - SURGICAL APRON PLACED;- PERFORMED DEGERMING WITH CHLORHEXIDINE DEGERMING AND ALCOHOLIC CHLORHEXIDINE; PREPARED ALL TABLE WITH MATERIAL TO BE PERFORMED;- SUCCESSFULLY PERFORMED, 01 PUNCTURE INSIDE THE BLOOD VESSEL WITH GOOD VENOUS RETURN, INTRODUCED 16CM OF CATHETER WITH NO SIGNS OF RESISTANCE, AT THE END OF THE INTRODUCTION PERFORMED FLUSH WITH 0.9% SOLUTION;- WHEN BREAKING THE INTRODUCER, 5 CM OF CATHETER WAS RETURNED, AND IT WAS TRIED TO BE INTRODUCED AGAIN, BUT PRESENTED RESISTANCE. WHEN REMOVING THE CATHETER COMPLETELY, ONLY 6 CM OF CATHETER WAS EVALUATED, REMAINING 10 CM INSIDE THE BLOOD VESSEL. THE ON DUTY PHYSICIAN DR. (B)(6) WAS NOTIFIED, A CHEST X-RAY WAS PERFORMED, AND SHE CONTACTED THE HEMODYNAMICS ON DUTY FOR MANAGEMENT DEFINITION (CATHETER LODGED IN THE VENA CAVA).(CATHETER LODGED IN THE VENA CAVA) -WAITING FOR AN ECHOCARDIOGRAM TO BE PERFORMED BY DR A.- AN ECHOCARDIOGRAM WILL BE PERFORMED LATER. IT WILL BE FORWARDED TO THE HEMODYNAMICS ON O
Patient problems: Foreign Body In Patient
MAUDE report 16277137 ↗MalfunctionDec 6, 2021Fluid/Blood Leak
THE CATHETER WAS LEFT FOR 10 DAYS. THE HOSPITAL USED A PRE-FILLED SYRINGE TO PERFORM NORMAL FLUSHING OPERATIONS. THE CATHETER WAS FOUND TO BE LEAKING, THE PATIENT WAS EXTUBATED, AND THE INFUSION FLUID WAS REPLACED. THIS NOT ONLY CAUSED ECONOMIC LOSSES, BUT ALSO ADDED EXTRA WORK TO NORMAL WORK. COMMUNICATE WITH PATIENTS TO AVOID DISPUTES.
Patient problems: Insufficient Information
MAUDE report 12933569 ↗MalfunctionNov 2, 2020Material Deformation
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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.
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