First PICC™ S/L Peripherally Inserted Central Catheter 384157Recalls & reported problems
Argon Medical Devices, Inc. · First PICC™ S/L Peripherally Inserted Central Catheter 18ga (4F) 1.35mm x 65cm · Class 2 · Implant
All models of First PICC S/L Peripherally Inserted Central Catheter (5)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00886333209682), received between Aug 19, 2020 and Jun 12, 2023 — classified as 7 malfunctions.
The most frequently reported specific device problem is “Physical Resistance/Sticking” (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
Device problems
- Physical Resistance/Sticking2
- Expulsion1
- Fluid/Blood Leak1
- Fracture1
- Material Perforation1
- Tear, Rip or Hole in Device Packaging1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
- Insufficient Information2
- Extravasation1
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 12, 2023Physical Resistance/Sticking; Physical Resistance/Sticking
¿PERFORMED PICC PASSAGE N.4 FR MONOLUMEM. SINGLE PUNCTURE. NO RESISTANCE TO CATHETER PROGRESSION. GUIDE WIRE PRESENTS SIGNIFICANT RESISTANCE IN ITS REMOVAL. CATHETER WAS WASHED WITH 50 ML OF 0.9% SALINE SOLUTION, BUT WITHOUT SUCCESS (GUIDE WIRE MAINTAINS RESISTANCE). GUIDE WIRE REMOVED ONLY AFTER ADMINISTRATION OF INTRAVENOUS DIPYRONE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17108224 ↗MalfunctionJun 12, 2023Physical Resistance/Sticking; Physical Resistance/Sticking
SUCCESSFUL (SINGLE PUNCTURE) PASSAGE OF PICC CATHETER N. 4 FR MONOLUMEN PERFORMED. NO RESISTANCE IN THE CATHETER PROGRESSION. HOWEVER, WHEN REMOVING THE GUIDE WIRE, IT PRESENTS IMPORTANT RESISTANCE. THE CATHETER WAS WASHED WITH 50 ML OF SALINE SOLUTION 0.9% TO LUBRICATE AND FACILITATE GUIDE WIRE REMOVAL. AFTER SEVERAL ATTEMPTS, THE GUIDE WIRE IS WITHDRAWN. X-RAY TO CONFIRM CATHETER POSITIONING, INTERNAL KINK VISUALIZED. ATTEMPTS WERE MADE TO REPOSITION THE DEVICE, BUT WITHOUT SUCCESS. CATHETER HAD TO BE REMOVED DUE TO MALPOSITION (HIGH RISK OF DVT)¿.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17108071 ↗MalfunctionAug 18, 2022Fracture
ON 07/21, THE PATIENT WAS PICCD FOR ATB IN A GERIATRIC CLINIC, ON 08/02 HE WAS BROUGHT TO THE HOSPITAL BECAUSE THE CATHETER WAS FRACTURED IN THE PROXIMAL PORTION CLOSE TO THE DISC, IT WAS NECESSARY TO CHANGE THE CATHETER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15250286 ↗MalfunctionAug 13, 2021Fluid/Blood Leak
PICC IMPLANTATION WAS PERFORMED FOR THE PATIENT ON JUNE 22, AND FLUID LEAKAGE WAS FOUND ON JULY 31.
Patient problems: Insufficient Information
MAUDE report 12320613 ↗MalfunctionAug 13, 2021Material Perforation
ACCORDING TO THE NURSING REPORT: "PICC WAS PASSED, AND AFTER TRACING THE GUIDE WIRE AND SALINIZING THE CATHETER, IT WAS OBSERVED THAT IT WAS PERFORATED NEAR THE OVAL DISC".
Patient problems: Insufficient Information
MAUDE report 12319702 ↗MalfunctionAug 11, 2021Tear, Rip or Hole in Device Packaging
"CATHETER INTRODUCED ON (B)(6) 2020 WITHOUT INTERCURRENCE. (B)(6) 2020 IT WAS IDENTIFIED IN THE STERILE DRESSING A SMALL HOLE IN THE CATHETER NEAR THE OVAL DISC."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12310263 ↗MalfunctionAug 19, 2020Expulsion
IT WAS VERIFIED THAT THE TIP OF THE GUIDE WIRE IS WITH EXTRAVASATION.
Patient problems: Extravasation
MAUDE report 10427549 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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