Cook G02054Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00827002020542), received between Oct 30, 2014 and Oct 30, 2014 — classified as 1 injury.

The most frequently reported specific device problem is “Material Separation” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryOct 30, 2014Material Separation

  CATHETER SEPARATED FROM HUB OF UNIT. CATHETER NO LONGER ON HUB AFTER UNDRESSING ENTRY SITE AFTER OPERATING ROOM. HAD TO GO BACK TO OPERATING ROOM IN ORDER TO REMOVE CATHETER. THE CATHETER HAD TO BE SURGICALLY REMOVED FROM LEFT WRIST. PATIENT HAD TO RETURN TO OPERATING ROOM TO BE RE-INTUBATED AND THEN SURGICAL INCISION WAS NECESSARY ON LEFT WRIST TO RETRIEVE MISSING CATHETER. SURGICAL INCISION ON LEFT WRIST WITH SCARRING FROM RETRIEVING CATHETER. UPDATE OCTOBER 20, 2014 - PER THE PHYSICIAN - THE CATHETER WAS WORKING FINE INTEROPERATIVELY AND DURING TRANSPORT TO THE PEDIATRIC ICU. ALMOST IMMEDIATELY AFTER THE PATIENT ARRIVED AT THE PEDIATRIC ICU, A NURSE NOTICED A FLUID BUBBLE AT THE HUB OF THE DEVICE. THE NURSE REMOVED THE DRESSING AND THE HUB CAME OFF WITH THE DRESSING. THERE WAS NO CATHETER ATTACHED. THEY PERFORMED AN X-RAY OF THE WRIST TO CONFIRM THAT THE CATHETER WAS STILL IN THE PATIENT. THEY THEN WENT BACK TO THE OPERATING ROOM TO SURGICALLY REMOVE THE CATHETER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 4223733 ↗