Cook G03265Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00827002032651), received between Dec 19, 2016 and Sep 27, 2017 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Fluid/Blood Leak” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjurySep 27, 2017Knotted

  THE PICC GUIDE WIRE KNOTTED IN THE VEIN DURING INSERTION. THE GUIDE WIRE WAS REMOVED ONCE IT WAS CAUGHT INSIDE THE VEIN. AN X-RAY WAS DONE AND NO GUIDE WIRE WAS RETAINED INSIDE THE PATIENT.

  Patient problems: No Code Available

  MAUDE report 6898372 ↗
• InjurySep 27, 2017Fluid/Blood Leak; Physical Property Issue

  IT WAS REPORTED THAT THE DEVICE LEAKED IN THE JUNCTION OF THE CATHETER AND THE HUB IN AT LEAST 6 CASES. ASIDE FROM REQUIRING AN EXTRA PUNCTURE, THE AFFECTED CHILDREN DID NOT EXPERIENCE ANY "DAMAGE."

  Patient problems: No Code Available

  MAUDE report 6896974 ↗
• MalfunctionSep 27, 2017Kinked; Material Separation; Unraveled Material

  THE DOCTOR REPORTED THAT THERE WAS DIFFICULTY REMOVING THE GUIDE WIRE FROM THE CATHETER AFTER PLACEMENT. THEREFORE, BOTH THE CATHETER AND THE GUIDE WIRE WERE REMOVED AS ONE UNIT AND REPLACED WITH A NEW KIT (PICC). THE DOCTOR STATED THAT THE KIT WAS USED ACCORDING TO THE INSTRUCTIONS. IT WAS REPORTED THAT WHEN THE DOCTOR OPENED THE FIRST DEVICE, THE CATHETER AND THE GUIDE WIRE WERE SEPARATED; THE CAP USED FOR HANDLING THE WIRE REMOVAL SEEMED UNDAMAGED. THERE WAS A SMALL KINK NOTED ABOUT 31.5 CM FROM THE CAP END (THIS WAS NOTED ON THE FIRST DEVICE PRIOR TO USE). THE SPIRALLY WRAPPED WIRE WAS SEPARATED FROM THE SOLID CORE, STARTING ABOUT 3 CM FROM THE TIP OF THE WIRE AND THE SPIRALLY WRAPPED WIRE WAS PULLED STRAIGHT/UNRAVELED, ACCORDING TO THE REPORTER THIS WAS NOTED ON THE FIRST DEVICE PRIOR TO USE.

  Patient problems: No Information

  MAUDE report 6896837 ↗
• InjuryFeb 27, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION FOR THIS REPORT WAS RECEIVED FROM THE EUROPEAN COMPETENT AUTHORITY MHRA. THE REPORT INDICATES THAT A PATIENT HAD A SINGLE LUMEN PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER (PICC) IMPLANTED THROUGH A RIGHT AXILLARY APPROACH. THE DATE OF INITIAL IMPLANTATION AND DURATION OF CLINICAL USE WAS NOT PROVIDED. THE REPORT STATES THAT THE PATIENT WAS IN A BOUNCER CHAIR AND BECAME AGITATED. WHEN THE STAFF NURSE ATTENDED TO THE CHILD, IT WAS NOTED THAT THE PICC LINE FROM THE RIGHT AXILLA WAS LYING ON THE FLOOR THE CLIP (SECURACATH) FOR SECURING THE PICC LINE IN PLACE REMAINED IN-SITU. THE STAFF NURSE WAS NOT SURE IF THE DEVICE FOUND LYING ON THE FLOOR ACCOUNTED FOR THE ENTIRE DEVICE OR IF A PORTION HAD FRAGMENTED AND REMAINED RETAINED IN THE PATIENT; THE NURSE INDICATES THERE ARE NO DEMARCATIONS ON THE DEVICE. THE PATIENT WAS TAKEN FOR X-RAYS TO RULE OUT ANY RETAINED FOREIGN OBJECTS. THE RESULTS OF THE X-RAY ANALYSIS WERE NOT PROVIDED. NO FURTHER INFORMATION IS AVAILABLE RELATING TO THE EVENT AND PATIENT CONDITION. IT WAS NOT REPORTED IF A NEW DEVICE WAS IMPLANTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6361087 ↗
• InjuryDec 19, 2016Separation Failure; Separation Failure

  THE LINE HAD BEEN INSERTED PRIOR ON (B)(6). THE LINE SNAPPED DURING REMOVAL ON (B)(6). SURGICAL INTERVENTION HAD TO BE PERFORMED TO RETRIEVE THE LINE LEFT IN THE PATIENT.

  Patient problems: No Code Available

  MAUDE report 6185220 ↗