First PICC™ S/L Peripherally Inserted Central Catheter Basic Kit 384222Recalls & reported problems
Argon Medical Devices, Inc. · First PICC™ S/L Peripherally Inserted Central Catheter Basic Kit with Statlock® Stabilization Device 26ga(1.9F) x 50cm · Class 2 · Implant
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00886333223220), received between Jul 1, 2020 and Apr 13, 2023 — classified as 1 injury, 4 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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Break2
- Adverse Event Without Identified Device or Use Problem1
- Blocked Connection1
- Fluid/Blood Leak1
- Malposition of Device1
Patient problems
- Insufficient Information2
- Blister1
- No Clinical Signs, Symptoms or Conditions1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 13, 2023Blocked Connection; Blocked Connection
PLACED ON 1/3 REMOVED ON 2/5 AFTER CLOTTING ¿ HAD PIVS TO COMPLETE THERAPY.¿
Patient problems: Insufficient Information
MAUDE report 16733292 ↗InjuryApr 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
NO CLOT WITH THIS PICC BUT THE INFANT HAD A ¿BLISTER, SIGNIFICANT SKIN INJURY¿ UNDER THE SECUREMENT DISK OF THE 384232. ACCORDING TO EMILY, THEY DID ALLOW TIME FOR THE ANTIMICROBIAL TO DRY.
Patient problems: Blister
MAUDE report 16733153 ↗MalfunctionSep 3, 2021Break
¿1.9 ARGON PICC, REFERENCE NUMBER (B)(4) MEDITECH NUMBER 0283159, LOT# 11290530 PLACED (B)(6) 2021; AS PER POLICY, DRESSING CHANGED ON (B)(6) 2021; DURING THE PROCESS OF REMOVING THE BIOOCCLUSIVE DRESSING, THE CATHETER BROKE IN HALF MID-CATHETER., NOT AT JUNCTION. THE NNP IMMEDIATELY REMOVED THE REMAINDER OF THE CATHETER AND THE BABY DID NOT SHOW ANY DISTRESS. THE BROKEN DEVICE WAS SAVED BY THE NURSE AND PLACED IN A BIOHAZARD BAG. IT WILL BE GIVEN THE MATERIALS MANAGEMENT FOR INVESTIGATION WITH THE COMPANY. A NEW PICC WAS PLACED ON THE BABY, A PROCEDURE THAT TOOK 2 HOURS AND 3 ATTEMPTS.¿ ¿WE HAVE PULLED ALL PRODUCTS WITH THE AFFECTED LOT NUMBER (11290530). WE LOCATED A TOTAL OF 3 AFFECTED LOT NUMBERS ASSOCIATED WITH THIS CONCERN.¿
Patient problems: Insufficient Information
MAUDE report 12425606 ↗MalfunctionMar 26, 2021Fluid/Blood Leak; Malposition of Device
MalfunctionJul 1, 2020Break
THE PICC BROKE IN HALF, THE CATHETER ITSELF.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10222130 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.