L-Cath PICC S/L 20 GA (3F) 1.0mm x 60cmRecalls & reported problems
Argon Medical Devices, Inc. · Peripherally Inserted Central Catheter · Class 2 · Implant
All models of L-Cath PICC S/L (2)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This Argon Medical L-Cath PICC is a long-term central line placed through the arm for giving fluids, medicines and nutrition. Most of the 28 reports describe the catheter cracking or breaking, sometimes at the hub so it stops flushing, and one report describes blood leaking from the crack. There are no deaths and 1 injury. One open recall, started in June 2026, covers leaking and cracking at the hub that can require replacing the line or lead to blockage.
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
- 28
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 00886333209828), received between Aug 18, 2022 and May 8, 2025 — classified as 1 injury, 27 malfunctions.
The most frequently reported specific device problem is “Crack” (27 reports).
1 FDA recall record name this device's identifier, 1 still open.
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
Recalls naming this device
- Jun 15, 2026Class IIOpen, Classified
Catheters, indicated for short/long-term peripheral access to central venous system for the administration of fluids, medications, nutrients; and sampling, may experience leaking and/or cracking at the hub, which may lead to replacement, inability to flush/aspirate catheter, catheter occlusion, therapy interruption, blood loss, tissue irritation, bloodstream infection.
Z-2803-2026 · Root cause: Device Design · Recall details · FDA record ↗
Most reported problems
Device problems
- Crack27
- Break6
- Fluid/Blood Leak1
Patient problems
- Insufficient Information26
- Hemorrhage/Blood Loss/Bleeding1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 25 most recent of 28 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 8, 2025Break; Crack; Break; Crack
THE REPORTER STATES THEY HAVE FOUND BROKEN/CRACKED PICCS FROM 4 DIFFERENT LOTS. NO DETAILS WERE PROVIDED ABOUT TYPE OF PROCEDURE, QUANTITY OF PICCS, DATES OF OCCURRENCE, NO INJURY WAS REPORTED.
Patient problems: Insufficient Information
MAUDE report 21990306 ↗MalfunctionMay 8, 2025Break; Crack; Break; Crack
THE REPORTER STATES THEY HAVE FOUND BROKEN/CRACKED PICCS FROM 4 DIFFERENT LOTS. NO DETAILS WERE PROVIDED ABOUT TYPE OF PROCEDURE, QUANTITY OF PICCS, DATES OF OCCURRENCE, NO INJURY WAS REPORTED.
Patient problems: Insufficient Information
MAUDE report 21990169 ↗MalfunctionMay 8, 2025Break; Crack; Break; Crack
THE REPORTER STATES THEY HAVE FOUND BROKEN/CRACKED PICCS FROM 4 DIFFERENT LOTS. NO DETAILS WERE PROVIDED ABOUT TYPE OF PROCEDURE, QUANTITY OF PICCS, DATES OF OCCURRENCE, NO INJURY WAS REPORTED,
Patient problems: Insufficient Information
MAUDE report 21990032 ↗MalfunctionMay 8, 2025Break; Crack; Break; Crack
THE REPORTER STATES THEY HAVE FOUND BROKEN/CRACKED PICCS FROM 4 DIFFERENT LOTS. NO DETAILS WERE PROVIDED ABOUT TYPE OF PROCEDURE, QUANTITY OF PICCS, DATES OF OCCURRENCE, NO INJURY WAS REPORTED.
Patient problems: Insufficient Information
MAUDE report 21989657 ↗MalfunctionJan 26, 2024Crack; Crack
INTERNAL HUB CRACKED AND NO FLUSHING WITHIN ONE DAY OF INSERTION (INSERTED IN MORNING, EVENT OCCURRED IN EVENING). DATE OF INSERTION: (B)(6) 2023 (<1 DAY IN SITU) PICC REMOVED AND REPLACED WITH NEW PICC.
Patient problems: Insufficient Information
MAUDE report 18586969 ↗InjuryJan 24, 2024Crack; Crack
PICC LINE DISCOVERED LEAKING BLOOD FROM CONNECTOR BETWEEN FEMALE AND OF PICC LINE AND LUER LOCK CONNECTOR FROM EXTENSION TUBING. DISCOVERED CRACK ON FEMALE END OF PICC LINE. DATE OF INSERTION: (B)(6) 2023 (IN SITU 5 DAYS) INJURY: UNDETERMINED AMOUNT OF BLOOD LOSS. INTERVENTION: PICC LINE REMOVED RESULTING IN LOSS OF TPN INFUSED AND UNDETERMINED AMOUNT OF BLOOD LOSS FROM DEFECTIVE PICC AREA. IV INSERTION INITIATED.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 18573283 ↗MalfunctionJul 31, 2023Break; Crack; Break; Crack
BROKEN CATHETER, THIS ONE CRACKING AT THE LEVEL OF THE PLASTIC JUNCTION. FOR THE MOMENT OUR BABIES ARE DOING WELL FOLLOWING THE INCIDENTS. BUT FROM THE PERSPECTIVE THAT OUR PREMATURE BABY, WHO IS BASICALLY A VERY FRAGILE BABY WITH NO IMMUNE DEFENCE, EACH INSTALLATION WHERE THE BREAKAGE OF THE CATHETERS HAS OCCURRED, WHICH HAS REQUIRED A 2ND OR EVEN A 3RD INSTALLATION, IS AN INJURY WHICH IS DIFFICULT TO JUSTIFIABLE AND THIS POSES SEVERAL MAJOR RISKS TO ITS FOLLOW-UP. THE DAMAGES ARE MANY. - A DELAY IN TREATMENT (PARENTERAL NUTRITION AND ANTIBIOTICS, HEMODYNAMIC INSTABILITY) WHICH IS ESSENTIAL TO ITS SURVIVAL -A POTENTIAL RISK OF INFECTION RELATED TO MULTIPLE CATHETER CHANGES. - A RISK OF DETERIORATION OF THE STATE OF HEALTH DURING INTRA-HOSPITAL TRANSPORT. -PAIN RELATED TO THE INSTALLATION PROCEDURE. -THE RISK OF WEIGHT LOSS AND HYPOGLYCEMIA. -A MAJOR SOURCE OF STRESS FOR FAMILIES. (FRENCH TRANSLATED TO ENGLISH).
Patient problems: Insufficient Information
MAUDE report 17425646 ↗MalfunctionJul 31, 2023Crack; Crack
BROKEN CATHETER, THIS ONE CRACKING AT THE LEVEL OF THE PLASTIC JUNCTION. FOR THE MOMENT OUR BABIES ARE DOING WELL FOLLOWING THE INCIDENTS. BUT FROM THE PERSPECTIVE THAT OUR PREMATURE BABY, WHO IS BASICALLY A VERY FRAGILE BABY WITH NO IMMUNE DEFENCE, EACH INSTALLATION WHERE THE BREAKAGE OF THE CATHETERS HAS OCCURRED, WHICH HAS REQUIRED A 2ND OR EVEN A 3RD INSTALLATION, IS AN INJURY WHICH IS DIFFICULT TO JUSTIFIABLE AND THIS POSES SEVERAL MAJOR RISKS TO ITS FOLLOW-UP. THE DAMAGES ARE MANY. A DELAY IN TREATMENT (PARENTERAL NUTRITION AND ANTIBIOTICS, HEMODYNAMIC INSTABILITY) WHICH IS ESSENTIAL TO ITS SURVIVAL. A POTENTIAL RISK OF INFECTION RELATED TO MULTIPLE CATHETER CHANGES. A RISK OF DETERIORATION OF THE STATE OF HEALTH DURING INTRA-HOSPITAL TRANSPORT. PAIN RELATED TO THE INSTALLATION PROCEDURE. THE RISK OF WEIGHT LOSS AND HYPOGLYCEMIA. A MAJOR SOURCE OF STRESS FOR FAMILIES. (FRENCH TRANSLATED TO ENGLISH).
Patient problems: Insufficient Information
MAUDE report 17425511 ↗MalfunctionJul 31, 2023Crack; Crack
BROKEN CATHETER, THIS ONE CRACKING AT THE LEVEL OF THE PLASTIC JUNCTION. FOR THE MOMENT OUR BABIES ARE DOING WELL FOLLOWING THE INCIDENTS. BUT FROM THE PERSPECTIVE THAT OUR PREMATURE BABY, WHO IS BASICALLY A VERY FRAGILE BABY WITH NO IMMUNE DEFENCE, EACH INSTALLATION WHERE THE BREAKAGE OF THE CATHETERS HAS OCCURRED, WHICH HAS REQUIRED A 2ND OR EVEN A 3RD INSTALLATION, IS AN INJURY WHICH IS DIFFICULT TO JUSTIFIABLE AND THIS POSES SEVERAL MAJOR RISKS TO ITS FOLLOW-UP. THE DAMAGES ARE MANY. A DELAY IN TREATMENT (PARENTERAL NUTRITION AND ANTIBIOTICS, HEMODYNAMIC INSTABILITY) WHICH IS ESSENTIAL TO ITS SURVIVAL A POTENTIAL RISK OF INFECTION RELATED TO MULTIPLE CATHETER CHANGES. A RISK OF DETERIORATION OF THE STATE OF HEALTH DURING INTRA-HOSPITAL TRANSPORT. PAIN RELATED TO THE INSTALLATION PROCEDURE. THE RISK OF WEIGHT LOSS AND HYPOGLYCEMIA. A MAJOR SOURCE OF STRESS FOR FAMILIES. (FRENCH TRANSLATED TO ENGLISH).
Patient problems: Insufficient Information
MAUDE report 17425440 ↗MalfunctionJul 31, 2023Crack; Crack
BROKEN CATHETER, THIS ONE CRACKING AT THE LEVEL OF THE PLASTIC JUNCTION. FOR THE MOMENT OUR BABIES ARE DOING WELL FOLLOWING THE INCIDENTS. BUT FROM THE PERSPECTIVE THAT OUR PREMATURE BABY, WHO IS BASICALLY A VERY FRAGILE BABY WITH NO IMMUNE DEFENCE, EACH INSTALLATION WHERE THE BREAKAGE OF THE CATHETERS HAS OCCURRED, WHICH HAS REQUIRED A 2ND OR EVEN A 3RD INSTALLATION, IS AN INJURY WHICH IS DIFFICULT TO JUSTIFIABLE AND THIS POSES SEVERAL MAJOR RISKS TO ITS FOLLOW-UP. THE DAMAGES ARE MANY. A DELAY IN TREATMENT (PARENTERAL NUTRITION AND ANTIBIOTICS, HEMODYNAMIC INSTABILITY) WHICH IS ESSENTIAL TO ITS SURVIVAL A POTENTIAL RISK OF INFECTION RELATED TO MULTIPLE CATHETER CHANGES. A RISK OF DETERIORATION OF THE STATE OF HEALTH DURING INTRA-HOSPITAL TRANSPORT. PAIN RELATED TO THE INSTALLATION PROCEDURE. THE RISK OF WEIGHT LOSS AND HYPOGLYCEMIA. A MAJOR SOURCE OF STRESS FOR FAMILIES. (FRENCH TRANSLATED TO ENGLISH).
Patient problems: Insufficient Information
MAUDE report 17425343 ↗MalfunctionJul 31, 2023Crack; Crack
BROKEN CATHETER, THIS ONE CRACKING AT THE LEVEL OF THE PLASTIC JUNCTION. FOR THE MOMENT OUR BABIES ARE DOING WELL FOLLOWING THE INCIDENTS. BUT FROM THE PERSPECTIVE THAT OUR PREMATURE BABY, WHO IS BASICALLY A VERY FRAGILE BABY WITH NO IMMUNE DEFENCE, EACH INSTALLATION WHERE THE BREAKAGE OF THE CATHETERS HAS OCCURRED, WHICH HAS REQUIRED A 2ND OR EVEN A 3RD INSTALLATION, IS AN INJURY WHICH IS DIFFICULT TO JUSTIFIABLE AND THIS POSES SEVERAL MAJOR RISKS TO ITS FOLLOW-UP. THE DAMAGES ARE MANY. A DELAY IN TREATMENT (PARENTERAL NUTRITION AND ANTIBIOTICS, HEMODYNAMIC INSTABILITY) WHICH IS ESSENTIAL TO ITS SURVIVAL A POTENTIAL RISK OF INFECTION RELATED TO MULTIPLE CATHETER CHANGES. A RISK OF DETERIORATION OF THE STATE OF HEALTH DURING INTRA-HOSPITAL TRANSPORT. PAIN RELATED TO THE INSTALLATION PROCEDURE. THE RISK OF WEIGHT LOSS AND HYPOGLYCEMIA. A MAJOR SOURCE OF STRESS FOR FAMILIES. (FRENCH TRANSLATED TO ENGLISH).
Patient problems: Insufficient Information
MAUDE report 17424121 ↗MalfunctionJul 31, 2023Crack; Crack
BROKEN CATHETER, THIS ONE CRACKING AT THE LEVEL OF THE PLASTIC JUNCTION. FOR THE MOMENT OUR BABIES ARE DOING WELL FOLLOWING THE INCIDENTS. BUT FROM THE PERSPECTIVE THAT OUR PREMATURE BABY, WHO IS BASICALLY A VERY FRAGILE BABY WITH NO IMMUNE DEFENCE, EACH INSTALLATION WHERE THE BREAKAGE OF THE CATHETERS HAS OCCURRED, WHICH HAS REQUIRED A 2ND OR EVEN A 3RD INSTALLATION, IS AN INJURY WHICH IS DIFFICULT TO JUSTIFIABLE AND THIS POSES SEVERAL MAJOR RISKS TO ITS FOLLOW-UP. THE DAMAGES ARE MANY. A DELAY IN TREATMENT (PARENTERAL NUTRITION AND ANTIBIOTICS, HEMODYNAMIC INSTABILITY) WHICH IS ESSENTIAL TO ITS SURVIVAL A POTENTIAL RISK OF INFECTION RELATED TO MULTIPLE CATHETER CHANGES. A RISK OF DETERIORATION OF THE STATE OF HEALTH DURING INTRA-HOSPITAL TRANSPORT. PAIN RELATED TO THE INSTALLATION PROCEDURE. THE RISK OF WEIGHT LOSS AND HYPOGLYCEMIA. A MAJOR SOURCE OF STRESS FOR FAMILIES. (FRENCH TRANSLATED TO ENGLISH).
Patient problems: Insufficient Information
MAUDE report 17424040 ↗MalfunctionJul 31, 2023Crack; Crack
BROKEN CATHETER, THIS ONE CRACKING AT THE LEVEL OF THE PLASTIC JUNCTION. FOR THE MOMENT OUR BABIES ARE DOING WELL FOLLOWING THE INCIDENTS. BUT FROM THE PERSPECTIVE THAT OUR PREMATURE BABY, WHO IS BASICALLY A VERY FRAGILE BABY WITH NO IMMUNE DEFENCE, EACH INSTALLATION WHERE THE BREAKAGE OF THE CATHETERS HAS OCCURRED, WHICH HAS REQUIRED A 2ND OR EVEN A 3RD INSTALLATION, IS AN INJURY WHICH IS DIFFICULT TO JUSTIFIABLE AND THIS POSES SEVERAL MAJOR RISKS TO ITS FOLLOW-UP. THE DAMAGES ARE MANY. A DELAY IN TREATMENT (PARENTERAL NUTRITION AND ANTIBIOTICS, HEMODYNAMIC INSTABILITY) WHICH IS ESSENTIAL TO ITS SURVIVAL A POTENTIAL RISK OF INFECTION RELATED TO MULTIPLE CATHETER CHANGES. A RISK OF DETERIORATION OF THE STATE OF HEALTH DURING INTRA-HOSPITAL TRANSPORT. PAIN RELATED TO THE INSTALLATION PROCEDURE. THE RISK OF WEIGHT LOSS AND HYPOGLYCEMIA. A MAJOR SOURCE OF STRESS FOR FAMILIES. (FRENCH TRANSLATED TO ENGLISH).
Patient problems: Insufficient Information
MAUDE report 17423928 ↗MalfunctionJul 28, 2023Crack; Crack
BROKEN CATHETER, THIS ONE CRACKING AT THE LEVEL OF THE PLASTIC JUNCTION. FOR THE MOMENT OUR BABIES ARE DOING WELL FOLLOWING THE INCIDENTS. BUT FROM THE PERSPECTIVE THAT OUR PREMATURE BABY, WHO IS BASICALLY A VERY FRAGILE BABY WITH NO IMMUNE DEFENCE, EACH INSTALLATION WHERE THE BREAKAGE OF THE CATHETERS HAS OCCURRED, WHICH HAS REQUIRED A 2ND OR EVEN A 3RD INSTALLATION, IS AN INJURY WHICH IS DIFFICULT TO JUSTIFIABLE AND THIS POSES SEVERAL MAJOR RISKS TO ITS FOLLOW-UP. THE DAMAGES ARE MANY. A DELAY IN TREATMENT (PARENTERAL NUTRITION AND ANTIBIOTICS, HEMODYNAMIC INSTABILITY) WHICH IS ESSENTIAL TO ITS SURVIVAL. A POTENTIAL RISK OF INFECTION RELATED TO MULTIPLE CATHETER CHANGES. A RISK OF DETERIORATION OF THE STATE OF HEALTH DURING INTRA-HOSPITAL TRANSPORT. PAIN RELATED TO THE INSTALLATION PROCEDURE. THE RISK OF WEIGHT LOSS AND HYPOGLYCEMIA. A MAJOR SOURCE OF STRESS FOR FAMILIES. (FRENCH TRANSLATED TO ENGLISH).
Patient problems: Insufficient Information
MAUDE report 17414564 ↗MalfunctionJul 28, 2023Crack; Crack
BROKEN CATHETER, THIS ONE CRACKING AT THE LEVEL OF THE PLASTIC JUNCTION. FOR THE MOMENT OUR BABIES ARE DOING WELL FOLLOWING THE INCIDENTS. BUT FROM THE PERSPECTIVE THAT OUR PREMATURE BABY, WHO IS BASICALLY A VERY FRAGILE BABY WITH NO IMMUNE DEFENCE, EACH INSTALLATION WHERE THE BREAKAGE OF THE CATHETERS HAS OCCURRED, WHICH HAS REQUIRED A 2ND OR EVEN A 3RD INSTALLATION, IS AN INJURY WHICH IS DIFFICULT TO JUSTIFIABLE AND THIS POSES SEVERAL MAJOR RISKS TO ITS FOLLOW-UP. THE DAMAGES ARE MANY. A DELAY IN TREATMENT (PARENTERAL NUTRITION AND ANTIBIOTICS, HEMODYNAMIC INSTABILITY) WHICH IS ESSENTIAL TO ITS SURVIVAL A POTENTIAL RISK OF INFECTION RELATED TO MULTIPLE CATHETER CHANGES. A RISK OF DETERIORATION OF THE STATE OF HEALTH DURING INTRA-HOSPITAL TRANSPORT. PAIN RELATED TO THE INSTALLATION PROCEDURE. THE RISK OF WEIGHT LOSS AND HYPOGLYCEMIA. A MAJOR SOURCE OF STRESS FOR FAMILIES. (FRENCH TRANSLATED TO ENGLISH).
Patient problems: Insufficient Information
MAUDE report 17414459 ↗MalfunctionJul 28, 2023Crack; Crack
BROKEN CATHETER, THIS ONE CRACKING AT THE LEVEL OF THE PLASTIC JUNCTION. FOR THE MOMENT OUR BABIES ARE DOING WELL FOLLOWING THE INCIDENTS. BUT FROM THE PERSPECTIVE THAT OUR PREMATURE BABY, WHO IS BASICALLY A VERY FRAGILE BABY WITH NO IMMUNE DEFENCE, EACH INSTALLATION WHERE THE BREAKAGE OF THE CATHETERS HAS OCCURRED, WHICH HAS REQUIRED A 2ND OR EVEN A 3RD INSTALLATION, IS AN INJURY WHICH IS DIFFICULT TO JUSTIFIABLE AND THIS POSES SEVERAL MAJOR RISKS TO ITS FOLLOW-UP. THE DAMAGES ARE MANY. A DELAY IN TREATMENT (PARENTERAL NUTRITION AND ANTIBIOTICS, HEMODYNAMIC INSTABILITY) WHICH IS ESSENTIAL TO ITS SURVIVAL. A POTENTIAL RISK OF INFECTION RELATED TO MULTIPLE CATHETER CHANGES. A RISK OF DETERIORATION OF THE STATE OF HEALTH DURING INTRA-HOSPITAL TRANSPORT. PAIN RELATED TO THE INSTALLATION PROCEDURE. THE RISK OF WEIGHT LOSS AND HYPOGLYCEMIA. A MAJOR SOURCE OF STRESS FOR FAMILIES. (FRENCH TRANSLATED TO ENGLISH).
Patient problems: Insufficient Information
MAUDE report 17414336 ↗MalfunctionJul 28, 2023Crack; Crack
BROKEN CATHETER, THIS ONE CRACKING AT THE LEVEL OF THE PLASTIC JUNCTION. FOR THE MOMENT OUR BABIES ARE DOING WELL FOLLOWING THE INCIDENTS. BUT FROM THE PERSPECTIVE THAT OUR PREMATURE BABY, WHO IS BASICALLY A VERY FRAGILE BABY WITH NO IMMUNE DEFENCE, EACH INSTALLATION WHERE THE BREAKAGE OF THE CATHETERS HAS OCCURRED, WHICH HAS REQUIRED A 2ND OR EVEN A 3RD INSTALLATION, IS AN INJURY WHICH IS DIFFICULT TO JUSTIFIABLE AND THIS POSES SEVERAL MAJOR RISKS TO ITS FOLLOW-UP. THE DAMAGES ARE MANY. A DELAY IN TREATMENT (PARENTERAL NUTRITION AND ANTIBIOTICS, HEMODYNAMIC INSTABILITY) WHICH IS ESSENTIAL TO ITS SURVIVAL A POTENTIAL RISK OF INFECTION RELATED TO MULTIPLE CATHETER CHANGES. A RISK OF DETERIORATION OF THE STATE OF HEALTH DURING INTRA-HOSPITAL TRANSPORT. PAIN RELATED TO THE INSTALLATION PROCEDURE. THE RISK OF WEIGHT LOSS AND HYPOGLYCEMIA. A MAJOR SOURCE OF STRESS FOR FAMILIES. (FRENCH TRANSLATED TO ENGLISH).
Patient problems: Insufficient Information
MAUDE report 17414205 ↗MalfunctionJul 28, 2023Crack; Crack
BROKEN CATHETER, THIS ONE CRACKING AT THE LEVEL OF THE PLASTIC JUNCTION. FOR THE MOMENT OUR BABIES ARE DOING WELL FOLLOWING THE INCIDENTS. BUT FROM THE PERSPECTIVE THAT OUR PREMATURE BABY, WHO IS BASICALLY A VERY FRAGILE BABY WITH NO IMMUNE DEFENCE, EACH INSTALLATION WHERE THE BREAKAGE OF THE CATHETERS HAS OCCURRED, WHICH HAS REQUIRED A 2ND OR EVEN A 3RD INSTALLATION, IS AN INJURY WHICH IS DIFFICULT TO JUSTIFIABLE AND THIS POSES SEVERAL MAJOR RISKS TO ITS FOLLOW-UP. THE DAMAGES ARE MANY. - A DELAY IN TREATMENT (PARENTERAL NUTRITION AND ANTIBIOTICS, HEMODYNAMIC INSTABILITY) WHICH IS ESSENTIAL TO ITS SURVIVAL -A POTENTIAL RISK OF INFECTION RELATED TO MULTIPLE CATHETER CHANGES. - A RISK OF DETERIORATION OF THE STATE OF HEALTH DURING INTRA-HOSPITAL TRANSPORT. -PAIN RELATED TO THE INSTALLATION PROCEDURE. -THE RISK OF WEIGHT LOSS AND HYPOGLYCEMIA. -A MAJOR SOURCE OF STRESS FOR FAMILIES. (FRENCH TRANSLATED TO ENGLISH).
Patient problems: Insufficient Information
MAUDE report 17414130 ↗MalfunctionJul 28, 2023Crack; Crack
BROKEN CATHETER, THIS ONE CRACKING AT THE LEVEL OF THE PLASTIC JUNCTION. FOR THE MOMENT OUR BABIES ARE DOING WELL FOLLOWING THE INCIDENTS. BUT FROM THE PERSPECTIVE THAT OUR PREMATURE BABY, WHO IS BASICALLY A VERY FRAGILE BABY WITH NO IMMUNE DEFENCE, EACH INSTALLATION WHERE THE BREAKAGE OF THE CATHETERS HAS OCCURRED, WHICH HAS REQUIRED A 2ND OR EVEN A 3RD INSTALLATION, IS AN INJURY WHICH IS DIFFICULT TO JUSTIFY AND THIS POSES SEVERAL MAJOR RISKS TO ITS FOLLOW-UP. THE DAMAGES ARE MANY: A DELAY IN TREATMENT (PARENTERAL NUTRITION AND ANTIBIOTICS, HEMODYNAMIC INSTABILITY) WHICH IS ESSENTIAL TO ITS SURVIVAL. POTENTIAL RISK OF INFECTION RELATED TO MULTIPLE CATHETER CHANGES. A RISK OF DETERIORATION OF THE STATE OF HEALTH DURING INTRA-HOSPITAL TRANSPORT. PAIN RELATED TO THE INSTALLATION PROCEDURE. THE RISK OF WEIGHT LOSS AND HYPOGLYCEMIA. A MAJOR SOURCE OF STRESS FOR FAMILIES. (FRENCH TRANSLATED TO ENGLISH)
Patient problems: Insufficient Information
MAUDE report 17414057 ↗MalfunctionJul 28, 2023Crack; Crack
BROKEN CATHETER, THIS ONE CRACKING AT THE LEVEL OF THE PLASTIC JUNCTION. FOR THE MOMENT OUR BABIES ARE DOING WELL FOLLOWING THE INCIDENTS. BUT FROM THE PERSPECTIVE THAT OUR PREMATURE BABY, WHO IS BASICALLY A VERY FRAGILE BABY WITH NO IMMUNE DEFENCE, EACH INSTALLATION WHERE THE BREAKAGE OF THE CATHETERS HAS OCCURRED, WHICH HAS REQUIRED A 2ND OR EVEN A 3RD INSTALLATION, IS AN INJURY WHICH IS DIFFICULT TO JUSTIFIABLE AND THIS POSES SEVERAL MAJOR RISKS TO ITS FOLLOW-UP. THE DAMAGES ARE MANY. - A DELAY IN TREATMENT (PARENTERAL NUTRITION AND ANTIBIOTICS, HEMODYNAMIC INSTABILITY) WHICH IS ESSENTIAL TO ITS SURVIVAL. -A POTENTIAL RISK OF INFECTION RELATED TO MULTIPLE CATHETER CHANGES. - A RISK OF DETERIORATION OF THE STATE OF HEALTH DURING INTRA-HOSPITAL TRANSPORT. -PAIN RELATED TO THE INSTALLATION PROCEDURE. -THE RISK OF WEIGHT LOSS AND HYPOGLYCEMIA. -A MAJOR SOURCE OF STRESS FOR FAMILIES. (FRENCH TRANSLATED TO ENGLISH).
Patient problems: Insufficient Information
MAUDE report 17413987 ↗MalfunctionJul 28, 2023Crack; Crack
BROKEN CATHETER, THIS ONE CRACKING AT THE LEVEL OF THE PLASTIC JUNCTION. FOR THE MOMENT OUR BABIES ARE DOING WELL FOLLOWING THE INCIDENTS. BUT FROM THE PERSPECTIVE THAT OUR PREMATURE BABY, WHO IS BASICALLY A VERY FRAGILE BABY WITH NO IMMUNE DEFENCE, EACH INSTALLATION WHERE THE BREAKAGE OF THE CATHETERS HAS OCCURRED, WHICH HAS REQUIRED A 2ND OR EVEN A 3RD INSTALLATION, IS AN INJURY WHICH IS DIFFICULT TO JUSTIFIABLE AND THIS POSES SEVERAL MAJOR RISKS TO ITS FOLLOW-UP. THE DAMAGES ARE MANY. -A DELAY IN TREATMENT (PARENTERAL NUTRITION AND ANTIBIOTICS, HEMODYNAMIC INSTABILITY) WHICH IS ESSENTIAL TO ITS SURVIVAL -A POTENTIAL RISK OF INFECTION RELATED TO MULTIPLE CATHETER CHANGES. - A RISK OF DETERIORATION OF THE STATE OF HEALTH DURING INTRA-HOSPITAL TRANSPORT. -PAIN RELATED TO THE INSTALLATION PROCEDURE. -THE RISK OF WEIGHT LOSS AND HYPOGLYCEMIA. -A MAJOR SOURCE OF STRESS FOR FAMILIES. (FRENCH TRANSLATED TO ENGLISH).
Patient problems: Insufficient Information
MAUDE report 17413917 ↗MalfunctionJul 28, 2023Crack; Crack
BROKEN CATHETER, THIS ONE CRACKING AT THE LEVEL OF THE PLASTIC JUNCTION. FOR THE MOMENT OUR BABIES ARE DOING WELL FOLLOWING THE INCIDENTS. BUT FROM THE PERSPECTIVE THAT OUR PREMATURE BABY, WHO IS BASICALLY A VERY FRAGILE BABY WITH NO IMMUNE DEFENCE, EACH INSTALLATION WHERE THE BREAKAGE OF THE CATHETERS HAS OCCURRED, WHICH HAS REQUIRED A 2ND OR EVEN A 3RD INSTALLATION, IS AN INJURY WHICH IS DIFFICULT TO JUSTIFIABLE AND THIS POSES SEVERAL MAJOR RISKS TO ITS FOLLOW-UP. THE DAMAGES ARE MANY. A DELAY IN TREATMENT (PARENTERAL NUTRITION AND ANTIBIOTICS, HEMODYNAMIC INSTABILITY) WHICH IS ESSENTIAL TO ITS SURVIVAL A POTENTIAL RISK OF INFECTION RELATED TO MULTIPLE CATHETER CHANGES. A RISK OF DETERIORATION OF THE STATE OF HEALTH DURING INTRA-HOSPITAL TRANSPORT. PAIN RELATED TO THE INSTALLATION PROCEDURE. THE RISK OF WEIGHT LOSS AND HYPOGLYCEMIA. A MAJOR SOURCE OF STRESS FOR FAMILIES. (FRENCH TRANSLATED TO ENGLISH).
Patient problems: Insufficient Information
MAUDE report 17413832 ↗MalfunctionJul 28, 2023Crack; Crack
BROKEN CATHETER, THIS ONE CRACKING AT THE LEVEL OF THE PLASTIC JUNCTION. FOR THE MOMENT OUR BABIES ARE DOING WELL FOLLOWING THE INCIDENTS. BUT FROM THE PERSPECTIVE THAT OUR PREMATURE BABY, WHO IS BASICALLY A VERY FRAGILE BABY WITH NO IMMUNE DEFENCE, EACH INSTALLATION WHERE THE BREAKAGE OF THE CATHETERS HAS OCCURRED, WHICH HAS REQUIRED A 2ND OR EVEN A 3RD INSTALLATION, IS AN INJURY WHICH IS DIFFICULT TO JUSTIFIABLE AND THIS POSES SEVERAL MAJOR RISKS TO ITS FOLLOW-UP. THE DAMAGES ARE MANY. - A DELAY IN TREATMENT (PARENTERAL NUTRITION AND ANTIBIOTICS, HEMODYNAMIC INSTABILITY) WHICH IS ESSENTIAL TO ITS SURVIVAL. -A POTENTIAL RISK OF INFECTION RELATED TO MULTIPLE CATHETER CHANGES. - A RISK OF DETERIORATION OF THE STATE OF HEALTH DURING INTRA-HOSPITAL TRANSPORT. -PAIN RELATED TO THE INSTALLATION PROCEDURE. -THE RISK OF WEIGHT LOSS AND HYPOGLYCEMIA. -A MAJOR SOURCE OF STRESS FOR FAMILIES. (FRENCH TRANSLATED TO ENGLISH).
Patient problems: Insufficient Information
MAUDE report 17413750 ↗MalfunctionJul 27, 2023Crack; Crack
BROKEN CATHETER, THIS ONE CRACKING AT THE LEVEL OF THE PLASTIC JUNCTION. FOR THE MOMENT OUR BABIES ARE DOING WELL FOLLOWING THE INCIDENTS. BUT FROM THE PERSPECTIVE THAT OUR PREMATURE BABY, WHO IS BASICALLY A VERY FRAGILE BABY WITH NO IMMUNE DEFENSE, EACH INSTALLATION WHERE THE BREAKAGE OF THE CATHETERS HAS OCCURRED, WHICH HAS REQUIRED A 2ND OR EVEN A 3RD INSTALLATION, IS AN INJURY WHICH IS DIFFICULT TO JUSTIFIABLE AND THIS POSES SEVERAL MAJOR RISKS TO ITS FOLLOW-UP. THE DAMAGES ARE MANY. A DELAY IN TREATMENT (PARENTERAL NUTRITION AND ANTIBIOTICS, HEMODYNAMIC INSTABILITY) WHICH IS ESSENTIAL TO ITS SURVIVAL -A POTENTIAL RISK OF INFECTION RELATED TO MULTIPLE CATHETER CHANGES. - A RISK OF DETERIORATION OF THE STATE OF HEALTH DURING INTRA-HOSPITAL TRANSPORT. -PAIN RELATED TO THE INSTALLATION PROCEDURE. -THE RISK OF WEIGHT LOSS AND HYPOGLYCEMIA. -A MAJOR SOURCE OF STRESS FOR FAMILIES. (FRENCH TRANSLATED TO ENGLISH).
Patient problems: Insufficient Information
MAUDE report 17407483 ↗MalfunctionJul 27, 2023Break; Crack; Break; Crack
BROKEN CATHETER, THIS ONE CRACKING AT THE LEVEL OF THE PLASTIC JUNCTION. FOR THE MOMENT OUR BABIES ARE DOING WELL FOLLOWING THE INCIDENTS. BUT FROM THE PERSPECTIVE THAT OUR PREMATURE BABY, WHO IS BASICALLY A VERY FRAGILE BABY WITH NO IMMUNE DEFENSE, EACH INSTALLATION WHERE THE BREAKAGE OF THE CATHETERS HAS OCCURRED, WHICH HAS REQUIRED A 2ND OR EVEN A 3RD INSTALLATION, IS AN INJURY WHICH IS DIFFICULT TO JUSTIFIABLE AND THIS POSES SEVERAL MAJOR RISKS TO ITS FOLLOW-UP. THE DAMAGES ARE MANY. - A DELAY IN TREATMENT (PARENTERAL NUTRITION AND ANTIBIOTICS, HEMODYNAMIC INSTABILITY) WHICH IS ESSENTIAL TO ITS SURVIVAL. -A POTENTIAL RISK OF INFECTION RELATED TO MULTIPLE CATHETER CHANGES. - A RISK OF DETERIORATION OF THE STATE OF HEALTH DURING INTRA-HOSPITAL TRANSPORT. -PAIN RELATED TO THE INSTALLATION PROCEDURE. -THE RISK OF WEIGHT LOSS AND HYPOGLYCEMIA. -A MAJOR SOURCE OF STRESS FOR FAMILIES. (FRENCH TRANSLATED TO ENGLISH).
Patient problems: Insufficient Information
MAUDE report 17407170 ↗
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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 · each recall links to the FDA recall notice
- 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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