Cook G02838Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00827002028388), received between Jun 11, 2018 and May 19, 2022 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Complete Blockage” (6 reports).

1 FDA recall record name this device's identifier.

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.

Recalls naming this device

1. May 25, 2022Completed

   The products may contain excess coating material on the outside and/or interior of the needle component. Potential adverse events that may occur if an affected product is used include a delay in the procedure, a prolonged procedure, or particulate entering the bloodstream which may result in pulmonary embolism or ischemia.

   Z-1362-2022 · Root cause: Nonconforming Material/Component · FDA record ↗

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 19, 2022Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED A HAIR-LIKE FIBER WAS NOTED IN THE PRIMARY PACKAGING OF A SINGLE LUMEN PRESSURE MONITORING SET. DURING AN ARTERIAL LINE PLACEMENT PROCEDURE, A HAIR STRAND WAS NOTED INSIDE THE PACKAGING. THE DEVICE WAS NOT OPENED. NO ADVERSE EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14436689 ↗
• MalfunctionJun 1, 2021Complete Blockage; Complete Blockage

  NO ADDITIONAL INFORMATION REGARDING PATIENT AND/OR EVENT DETAILS HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11915293 ↗
• MalfunctionApr 14, 2020Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT A WIRE GUIDE WOULD NOT PASS THROUGH THE NEEDLES INCLUDED IN TWO SINGLE LUMEN PRESSURE MONITORING SETS. THE USER WAS ATTEMPTING TO USE THE SELDINGER TECHNIQUE DURING AN ARTERIAL LINE PLACEMENT PROCEDURE WHEN THE DEVICES FAILED. NO ADVERSE EFFECTS TO THE PATIENT WERE REPORTED OTHER THAN "REQUIRING MULTIPLE STICKS".

  Patient problems: Needle Stick/Puncture

  MAUDE report 9959019 ↗
• MalfunctionApr 13, 2020Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT A WIRE GUIDE WOULD NOT PASS THROUGH THE NEEDLES INCLUDED IN TWO SINGLE LUMEN PRESSURE MONITORING SETS. DURING PREPARATION FOR PLACING AN ARTERIAL LINE IN A PEDIATRIC PATIENT IN THE USER FACILITY'S ICU, IT WAS NOTED THAT THE NEEDLES "SEEMED OBSTRUCTED DURING FLUSHING". ONE OF THE NEEDLES APPEARED COMPLETELY OBSTRUCTED WHILE THE OTHER NEEDLE HAD A "HIGH PRESSURE STREAM". THE DEVICES WERE DISCARDED AND A THIRD DEVICE WAS INTRODUCED TO COMPLETE THE PROCEDURE. THE PATIENT'S OUTCOME WAS DESCRIBED AS "GOOD". NO ADVERSE EFFECTS TO THE PATIENT HAVE BEEN REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 9954868 ↗
• MalfunctionApr 13, 2020Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT THE WIRE GUIDES WOULD NOT PASS THROUGH THE NEEDLES INCLUDED IN TWO SINGLE LUMEN PRESSURE MONITORING SETS FROM THE SAME LOT DURING AN ARTERIAL LINE PLACEMENT, CITING THAT THE WIRE IS CATCHING. THE FIRST DEVICE WAS BEING IMPLANTED IN THE PEDIATRIC CARDIAC INTENSIVE CARE UNIT (PCICU) BUT DID NOT MAKE PATIENT CONTACT AS IT WAS TESTED PRIOR TO THE PROCEDURE. ANOTHER DEVICE WAS THEN OBTAINED, BUT THE SAME ISSUE WAS EXPERIENCED. A THIRD DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE USER FACILITY HAS STATED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Patient Involvement

  MAUDE report 9954160 ↗
• MalfunctionNov 12, 2019Complete Blockage; Contamination; Complete Blockage; Contamination

  NO ADDITIONAL PATIENT/EVENT INFORMATION HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: No Patient Involvement

  MAUDE report 9309946 ↗
• MalfunctionNov 12, 2019Complete Blockage; Contamination; Complete Blockage; Contamination

  NO ADDITIONAL PATIENT/EVENT INFORMATION HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: No Patient Involvement

  MAUDE report 9309782 ↗
• MalfunctionJun 6, 2019Delivered as Unsterile Product; Delivered as Unsterile Product

  NO NEW EVENT DESCRIPTION INFORMATION TO REPORT AT THIS TIME.

  Patient problems: No Patient Involvement

  MAUDE report 8675793 ↗
• MalfunctionJun 11, 2018Partial Blockage

  IT WAS REPORTED THAT THE NEEDLE OF THE SINGLE LUMEN PRESSURE MONITORING SET WAS BLOCKED, AND FLUID WOULD ONLY FLOW THROUGH IT AT EXTREMELY HIGH PRESSURE. THE DEVICE DID NOT MAKE PATIENT CONTACT, AND NO INJURIES OR ADDITIONAL PROCEDURES WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7589153 ↗