First PICC™ S/L Peripherally Inserted Central Catheter Basic Kit 384221Recalls & reported problems
Argon Medical Devices, Inc. · First PICC™ S/L Peripherally Inserted Central Catheter Basic Kit 26GA (1.9F) x 50cm · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This Argon Medical First PICC S/L line is a peripherally inserted central catheter (PICC) basic kit, a thin tube placed through the skin into a vein for short-term use. The 55 reports mostly describe the line breaking, cracking, rupturing or leaking — including splitting during removal and the stiff inserter breaking during placement — with 2 injuries and no deaths. Most reports note no harm to the patient, though a few mention fluid leaking into surrounding tissue. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 53
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 53 adverse event reports that list this exact device (DI 00886333209743), received between Apr 17, 2018 and Jul 31, 2025 — classified as 53 malfunctions.
The most frequently reported specific device problem is “Break” (15 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.
Reports received per month
Most reported problems
Device problems
- Break15
- Material Rupture15
- Fluid/Blood Leak11
- Crack7
- Material Puncture/Hole7
- Fracture3
- Detachment of Device or Device Component2
- Leak/Splash2
Patient problems
- No Clinical Signs, Symptoms or Conditions20
- Insufficient Information17
- No Known Impact Or Consequence To Patient8
- Extravasation2
- Device Embedded In Tissue or Plaque1
- Foreign Body In Patient1
- Laceration(s)1
- Localized Skin Lesion1
Recent adverse event reports
The 25 most recent of 53 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 31, 2025Material Rupture; Material Rupture
PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) WITH 34 DAYS OF USE. BLEEDING OBSERVED IN THE DRESSING; UPON PERMEABILIZATION, THE CATHETER IS FOUND TO BE PARTIALLY RUPTURED IN FLEXIBLE SILICONE. A NEW CATHETER WAS PLACED AS THE TREATMENT HAD NOT YET BEEN COMPLETED.
Patient problems: Insufficient Information
MAUDE report 22682002 ↗MalfunctionJul 23, 2025Break; Break
REPORTER INDICATED PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) HAD A PROBLEM DURING PUNCTURE, WITH THE MANDREL BREAKING IN HALF ON ONE SIDE ONLY WHEN ATTEMPTING TO REMOVE IT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22579723 ↗MalfunctionJun 16, 2024Break; Break
MEDWATCH REPORT RECEIVED INDICATING, "INFANT'S PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) WAS LEAKING FOR UNKNOWN AMOUNT OF TIME. RECEIVED ORDER TO TRY AN OVER AND UNDER PICC TO REMOVE INITIAL PICC. PICC DRESSING REMOVED INFANT CLEANED AND DRAPED UNDER STERILE CONDITIONS. PICC LINE CUT RIGHT BELOW HEART. INTRODUCER GUIDED THROUGH SKIN AND BEGAN TO PULL PICC LINE OUT. PICC LINE SNAPPED AND WAS AT INSERTION SITE. PICC PULLED OUT EASILY AND INTRODUCER AGAIN PLACED OVER PICC LINE AND BEGAN TO PULL REMAINDER OF PICC. PICC SNAPPED AGAIN AND TOTAL OF 8 CM OBTAINED. 10CM WAS WHERE PICC LINE WAS CUT. PRESSURE IMMEDIATELY APPLIED TO ARMPIT AND ABOVE SITE".
Patient problems: Insufficient Information
MAUDE report 19544984 ↗MalfunctionApr 18, 2024Break; Break
BREAKAGE OF THE INTRODUCER AT THE TIME OF PASSAGE, PREVENTING THE CATHETER FROM PASSING THROUGH.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19139522 ↗MalfunctionApr 18, 2024Break; Break
BREAKAGE OF THE INTRODUCER AT THE TIME OF PASSAGE, PREVENTING THE CATHETER FROM PASSING THROUGH.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19138918 ↗MalfunctionApr 18, 2024Fracture; Fracture
A REPORTER INDICATED A PICC CATHETER WITH SUSPECTED QUALITY DEVIATION THAT FRACTURED DURING PASSAGE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19137848 ↗MalfunctionMar 11, 2024Material Rupture; Material Rupture
REPORTER INDICATE CATHETER RUPTURED AND HAD MICRO-HOLES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18879513 ↗MalfunctionAug 29, 2023Blocked Connection; Blocked Connection
WE RECENTLY HAD AN ISSUE WITH ONE OF OUR PICC LINES THAT STOPPED FLUSHING IN A PATIENT. I HAVE THE PICC IN MY OFFICE BUT OF COURSE WE DO NOT HAVE THE LOT NUMBER AS THE PACKAGING WAS THROWN AWAY¿. MORE INFO PROVIDED: 8/12/2023, AT 0100 IV PUMP WAS READING OCCLUDED, FLUSH ATTEMPTED UNSUCCESSFULLY, AND THE LINE IS BUBBLING ABOVE THE HEART. PICC HAD TO BE REMOVED AND REPLACED. THE HARM DONE TO THE PT IS THAT ANOTHER INVASIVE PROCEDURE WAS REQUIRED.¿ DATE OF PICC INSERTION (B)(6) 2023.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 17643170 ↗MalfunctionJun 12, 2023Crack; Crack
¿WHEN PUNCTURING THE PATIENT'S CEPHALIC AND JUGULAR VEIN, THE TWO INTRODUCER UNITS PRESENTED SILICONE CRACKING, MAKING IT IMPOSSIBLE TO PASS THE CATHETER, AS WELL AS RUPTURING THE BLOOD VESSEL.¿
Patient problems: Rupture
MAUDE report 17107842 ↗MalfunctionMar 8, 2023Break; Break
DURING THE PICC INSERTION PROCEDURE, I NOTICE THAT THE PICC CATHETER HAS THE MARKINGS SLIGHTLY OFF, I INSERT THE CATHETER, AND DURING THE CATHETER INSERTION, I HAVE DIFFICULTIES SEEING THE MARKINGS. AFTER A CHEST X-RAY TO VERIFY THE CATHETER POSITION, I VERIFY THAT THE CATHETER REMAINED IN THE ARM REGION, REQUIRING CATHETER REMOVAL.¿
Patient problems: Foreign Body In Patient
MAUDE report 16502704 ↗MalfunctionFeb 14, 2023Material Frayed; Dull, Blunt; Material Frayed; Dull, Blunt
WHEN PERFORMING THE PUNCTURE, THE TIP OF THE INTRODUCER IS BLUNT, INJURING THE PATIENT, NOT ALLOWING A NEW ADEQUATE PUNCTURE. IN OTHER PUNCTURES, IT WAS LACERATED, WITH IRREGULAR EDGES AND WHEN REINSERTING IT, IT WAS POSSIBLE TO FEEL (AS REPORTED BY THE PROFESSIONALS) THAT IT WAS INJURING THE TISSUE, RUPTURING THE PATIENTS VEIN (SEE ATTACHED PHOTO). THE PATIENTS WITH PICC PASSAGE CRITERIA ARE EXTREME PREMATURE AND WITH FRAGILE VENOUS NET, THE FACT CAUSED DAMAGE TO THE PATIENTS, INCREASING THE RISKS AND EXPOSING THE NB UNNECESSARILY, SOMETIMES THE PROCEDURE WAS GIVEN UP FOR INSERTION OF ANOTHER CATHETER.
Patient problems: Laceration(s); Unspecified Tissue Injury
MAUDE report 16373161 ↗MalfunctionAug 18, 2022Fluid/Blood Leak
"WHEN WASHING THE PICC IN THE RIGHT UPPER LIMB WITH 0.9% SALINE SOLUTION PRIOR TO THE INSTALLATION OF A NEW PARENTERAL NUTRITION BAG, SERUM LEAKAGE WAS OBSERVED IN THE EXTERNAL EXTENSION OF THE CATHETER. A NEW ATTEMPT TO PASS THE PICC WAS UNSUCCESSFUL. PERIPHERAL VENOUS ACCESS WAS THEN PUNCTURED IN THE CEPHALIC REGION WITH DIFFICULTY DUE TO THE NEWBORN'S CLINICAL CONDITION (CAPILLARY FRAGILITY AND ANASARCA). CONTAMINATED SAMPLE WAS DISCARDED."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15254654 ↗MalfunctionDec 16, 2021Material Puncture/Hole
4 - PUNCTURE IN THE CANNON OF THE CATHETER. ((B)(6) 2021)
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13018647 ↗MalfunctionDec 16, 2021Break
3 - BREAK NEAR THE CANNON ((B)(6)).
Patient problems: Insufficient Information
MAUDE report 13018582 ↗MalfunctionDec 16, 2021Break
2 - BREAK NEAR THE CANNULA ((B)(6)).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13018533 ↗MalfunctionDec 16, 2021Defective Component
"4 (FOUR) TECHNICAL COMPLAINTS WERE NOTIFIED INVOLVING THE FOLLOWING HOSPITAL MATERIAL: FIRST PICC BASIC KIT NEONATAL" DEFECTIVE PUNCTURE NEEDLE ((B)(6)).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13018458 ↗MalfunctionDec 8, 2021Leak/Splash; Material Puncture/Hole
"NEWBORN WITH PICC CATHETER INSERTED ON (B)(6) 2021, RECEIVING CONTINUOUS INFUSION OF BASAL SALINE SOLUTION BY INFUSION PUMP, OBSERVED LEAKAGE OF SALINE SOLUTION IN BED, CATHETER WAS WASHED AND IT WAS VERIFIED THAT IT WAS PUNCTURED".
Patient problems: Insufficient Information
MAUDE report 12965673 ↗MalfunctionNov 29, 2021Material Rupture
CATHETER RUPTURE WHEN INSERTED IN THE PATIENT".
Patient problems: Insufficient Information
MAUDE report 12887972 ↗MalfunctionNov 29, 2021Material Rupture
CATHETER RUPTURE WHEN INSERTED IN THE PATIENT".
Patient problems: Insufficient Information
MAUDE report 12887899 ↗MalfunctionNov 17, 2021Break
CATHETER IN UPPER LIMB BROKE DURING DRESSING CHANGE
Patient problems: Insufficient Information
MAUDE report 12832300 ↗MalfunctionOct 1, 2021Fluid/Blood Leak; Material Puncture/Hole
NEWBORN WITH PICC CATHETER INSERTED ON (B)(6) 2021, RECEIVING CONTINUOUS INFUSION OF BASAL SALINE SOLUTION BY INFUSION PUMP, SERUM LEAKAGE WAS OBSERVED IN THE BED, THE CATHETER WAS WASHED, AND IT WAS FOUND TO BE PUNCTURED
Patient problems: Insufficient Information
MAUDE report 12565605 ↗MalfunctionSep 17, 2021Crack
"PICC CATHETER, 19 (FR) PRESENTED: PARTIAL RUPTURE (CRACK) AT THE EXTERNAL END OF THE PRODUCT (ACCORDING TO ATTACHED PHOTO). INTERCONNECTED CATHETER FOR PARENTERAL NUTRITION ADMINISTRATION, WITH SOLUTION EXCHANGE ONCE A DAY AND ANTIBIOTIC THERAPY OF 8/ HOURS. EVENT OCCURRED SIX TIMES IN THE UNIT, REQUIRING EXCHANGE OF THE SAME CATHETERS, AT THE REQUEST OF THE RESPONSIBLE MEDICAL TEAM. IN ALL THE CASES MENTIONED ABOVE, THE CATHETER PERMANENCE TIME WAS LESS THAN FIVE DAYS. INSTITUTIONAL PROTOCOL WAS REVIEWED, AND NO FAILURE IN MAINTENANCE WAS INDICATED THAT WOULD JUSTIFY THE RUPTURES AND/OR FAILURE IN THE MATERIAL BEFORE INSERTION.
Patient problems: Insufficient Information
MAUDE report 12492518 ↗MalfunctionSep 3, 2021Material Fragmentation; Material Rupture
CENTRAL CATHETER WAS INSERTED IN A NEWBORN ON (B)(6) 2021, DURING THE COURSE OF THE SAME DAY THE DEVICE WAS REPLACED. AT THE OCCASION THERE WAS RUPTURE OF THE DEVICE, WITH DISPLACEMENT OF AN 8CM FRAGMENT TO THE CARDIAC AREA. THE REMOVAL OF THE FRAGMENT OCCURRED ON (B)(6) 2021 BY THE VASCULAR SURGERY TEAM. SOON AFTER THE PROCEDURE, THE PATIENT HAD A CLINICAL WORSENING OF THE CONDITION, EVOLVING WITH TONIC-CLONIC MOVEMENTS. ADVERSE EVENT: TONIC CLONIC SEIZURES ."
Patient problems: Insufficient Information
MAUDE report 12425509 ↗MalfunctionJul 21, 2021Break; Detachment of Device or Device Component
¿PLEASE BE ADVISED THAT ONE OF OUR 1.9 FRENCH CATHS WAS FOUND BROKEN, SNAPPED AT THE HUB, PRODUCT NUMBER AR384221. ON (B)(6) 2021 (PICC WAS PLACED (B)(6)), DRESSING INTACT, ENTIRE CATHETER REMOVED, NO HARM TO PATIENT DUE TO ACTIVE RECOVERY BY NURSING.¿
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12205721 ↗MalfunctionJun 24, 2021Material Puncture/Hole
WHEN CONCLUDED DRESSING PLACEMENT, A HOLE WAS OBSERVED NEAR THE CATHETER HUB WITH LEAKAGE OF PERIPHERAL PARENTERAL NUTRITION.
Patient problems: Insufficient Information
MAUDE report 12062318 ↗
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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