Neonatal Procedure Tray 384835Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00886333210091), received between Jul 1, 2020 and May 20, 2021 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Crack” (1 report).

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.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 20, 2021Leak/Splash

  MICROBORE EXTENSION SET WAS LEAKING WHERE THE TUBE AND CONNECTOR MEET.

  Patient problems: Insufficient Information

  MAUDE report 11860902 ↗
• MalfunctionSep 28, 2020Defective Device

  WE HAVE HAD 3 FAILURES THIS YEAR - TUBING NOT SAVED. ALL HAVE BEEN NEAR THE FEMALE END WHERE THE CLAVE ATTACHES. THEY WERE ALL LONG DURATION SITUATIONS - AT LEAST WEEKS AND I ASSUMED WERE RELATED TO REPETITIVE MOTION IN THAT AREA SINCE THE REST OF THE EXTENSION IS SECURED IN A LOOP TO PROTECT THE LINE FROM BEING PULLED ON ACCIDENTALLY. AT LEAST ONE FAILURE HAD A CLABSI EVENT ASSOCIATED WITH IT. BECAUSE OF THE MOTION ISSUE WITH MECHANICAL STRESS, I HONESTLY DIDN'T THINK THERE WAS A "PROBLEM" WITH THE PRODUCT. EXTENSION SETS CHANGED. PICC LEFT IN PLACE. ONE CLABSI TREATED. NO CUSTOMER CLAIM OF SET FAILURE AS THE CAUSE.

  Patient problems: Unspecified Infection

  MAUDE report 10591821 ↗
• MalfunctionJul 1, 2020Crack; Fluid/Blood Leak

  I WANT TO REPORT THAT ONE OF OUR NEW, CONVERTED PICCS, ARGON LOT #11259401, WAS LEAKING AND CAUSED THE LINE TO CLOT OFF. THIS RESULTED IN THE BABY HAVING TO HAVE ANOTHER PROCEDURE TO INSERT A NEW PICC AND PUTS THE BABY AT RISK FOR INFECTION. I¿M FAIRLY CERTAIN THAT THIS IS THE FIRST TIME THAT WE HAVE USED THIS NEW PICC. THIS PICC WAS PLACED IN THE RIGHT ANTECUBITAL VEIN ON A TERM BABY FOR LONG TERM ANTIBIOTIC USE ON TUESDAY, MAY 12TH. THE TUBING WAS CHANGED ON THURSDAY, MAY 14TH AND AT THAT TIME JUST HAD A ¼ NORMAL SALINE WITH 0.5 UNITS HEPARIN PER ML RUNNING TO KEEP OPEN AT 0.5ML AN HOUR WITH INTERMITTENT MEDICATION DOSES OF 6.6ML OVER 30 MINUTES EVERY 8 HOURS. ON SATURDAY, MAY 16TH AT 1500 THE TO KEEP OPEN RATE WAS INCREASED TO 1ML/HR. AT 1800 ON THE SAME DAY, THE NURSE NOTED THAT IT WAS LEAKING. IT WAS DETERMINED AFTER TROUBLESHOOTING BY THE RN AND THE NNP THAT IT WAS THE EXTENSION SET (THE SHORT TUBING THAT CONNECTS THE PICC TO THE TUBING) WAS CRACKED AT THE FEMALE HUB AND WAS LEAKING FROM THAT SITE. IT WAS REMOVED FROM THE PICC AND THE TUBING CONNECTED DIRECTLY TO THE PICC BUT BY THAT TIME THE LINE WAS NOTED TO BE CLOTTED AND HAD TO BE REMOVED AND REPLACED. I HAVE THE CRACKED

  Patient problems: No Code Available

  MAUDE report 10222135 ↗