Statlock IV Select Start Kit IVK0135Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00801741082535), received between Jul 26, 2018 and Aug 17, 2018 — classified as 10 malfunctions.

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

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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 17, 2018Fluid/Blood Leak

  IT WAS REPORTED THAT THE IV WAS SUCCESSFULLY HAND FLUSHED WITH SALINE AND WITH POWER INJECTOR FOR TESTING, BUT A SMALL AMOUNT OF CONTRAST INFILTRATED INTO PATIENT'S ARM DURING INJECTION. A NEW DEVICE HAD TO BE PLACED BY THE CT TECH. NO PATIENT INJURY WAS REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 7792557 ↗
• MalfunctionAug 17, 2018Disconnection

  IT WAS REPORTED THAT THE IV WAS HAND FLUSHED WITH SALINE AND WITH THE POWER INJECTOR FOR TESTING, WHICH WORKED WELL, BUT BECAME DISCONNECTED DURING THE INJECTION OF CONTRAST. A NEW DEVICE HAD TO BE PLACED BY THE CT TECH. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7792553 ↗
• MalfunctionAug 17, 2018Disconnection

  IT WAS REPORTED THAT THE IV WAS TEST FLUSHED WITH SALINE BY HAND WITH NO ISSUES, BUT THE IV DISCONNECTED DURING THE POWER INJECTOR FLUSH. THE CT TECH TOOK OFF THE STATLOCK AND EXTENSION TUBING AND PLACED A NEW CONNECTOR ONTO THE IV. THE TECH THEN FLUSHED BY HAND AND WITH THE POWER INJECTOR WITH NO ISSUES; THE IV WORKED FINE AND THE SCANS WERE COMPLETED. IT WAS NOTED BY COMPLAINANT THAT "THIS ISSUE CAUSED A DELAY IN PATIENT CARE. THERE WAS A POTENTIAL RISK FOR IV INFILTRATION, REPEAT SCANS OR INSUFFICIENT STUDIES. BUT THIS CASE JUST CAUSED A DELAY IN CARE." NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7792536 ↗
• MalfunctionAug 17, 2018Disconnection; Fluid/Blood Leak

  IT WAS REPORTED THAT THE IV WAS TEST FLUSHED WITH SALINE BY HAND AND THEN AGAIN WITH THE POWER INJECTOR WITH NO ISSUES. DURING THE TEST BOLUS, THE IV BECAME DISCONNECTED AND LEAKED ALL OVER THE PATIENT AND THE TABLE. THE CT TECH HAD TO "TAKE ALL OF THE TAPE, THE CONNECTOR AND THE BLUE LOCKING PIECE OFF OF THE IV HUB, AND ATTACH THEIR OWN CONNECTOR TO THE IV." THEN THE CT TECH CLEANED UP THE PATIENT AND THE TABLE AND THE SCAN WAS COMPLETED. THIS CAUSED A DELAY IN PATIENT CARE AND HELD UP OUR SCAN ROOM LONGER THAN USUAL. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7792521 ↗
• MalfunctionAug 17, 2018Break

  IT WAS REPORTED THAT THE IV WAS STARTED BY THE ER IN THE LEFT AC. THE IV WAS TESTED BY HAND BY THE CT TECH WITH 10 CC OF SALINE FOLLOWED BY 30 CC @ 5 CC/SEC WITH THE CONTRAST INJECTOR WITH NO ISSUES. DURING THE FIRST ATTEMPT OF CONTRAST INJECTION THE IV "FELL APART." THE CT TECH RECONNECTED THE IV AND TEST FLUSHED WITH THE INJECTOR AGAIN WITH NO ISSUES. THE IV INFILTRATED APPROX. 50 CC OF CONTRAST IN THE PATIENT'S LEFT FOREARM. A NEW IV WAS PLACED IN THE PATIENT'S RIGHT ARM FOR THE THIRD ATTEMPT, THE CT TECH TEST FLUSHED WITH INJECTOR WITH NO ISSUES AND THE EXAM WAS SUCCESSFUL. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7792519 ↗
• MalfunctionAug 17, 2018Disconnection

  IT WAS REPORTED THAT THE IV WAS TEST FLUSHED WITH SALINE BY HAND AND WITH THE POWER INJECTOR WITH NO ISSUES. THE IV BECAME DISCONNECTED DURING THE CONTRAST INJECTION. IT WAS NOTED BY COMPLAINANT THAT "THIS ISSUE CAUSED A DELAY IN PATIENT CARE. THERE WAS A POTENTIAL RISK FOR IV INFILTRATION, REPEAT SCANS OR INSUFFICIENT STUDIES. THIS CASE CAUSED AN INADEQUATE SCAN/TEST RESULT, AND THE PATIENT MAY HAVE TO RETURN FOR A REPEAT STUDY WITH UNNECESSARY ADDITIONAL RADIATION." NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7792513 ↗
• MalfunctionAug 17, 2018Disconnection

  IT WAS REPORTED THAT THE IV WAS TEST FLUSHED WITH SALINE BY HAND AND THEN AGAIN WITH THE POWER INJECTOR WITH NO ISSUES. DURING THE CONTRAST INJECTION THE IV BECAME DISCONNECTED; HOWEVER THIS WAS NOT DETECTED UNTIL THE IMAGES CAME UP NOT SHOWING ANY CONTRAST AND THE SCAN HAD TO BE REPEATED. IT WAS NOTED BY THE COMPLAINANT THAT "THIS PATIENT WAS A VERY DIFFICULT PATIENT TO BEGIN WITH, WEIGHING (B)(6); WE HAD TO STRAP HIM IN TIGHT TO FIT HIM THROUGH THE SCANNER. HE WAS VERY UNCOMFORTABLE, NERVOUS AND VERY UPSET WHEN WE TOLD HIM THAT WE NEEDED TO FIX HIS IV AND REPEAT THE SCAN. THE IV CAME APART AT THE HUB, UNDER THAT BLUE LOCKING PIECE, AND A BUNCH OF TAPE AND THE WHITE STICKERS. THAT MUST HAVE BEEN WHAT HELPED HOLD IT TOGETHER DURING THE SALINE FLUSHES. ONCE THIS BLUE PIECE, TAPE AND THE EXTENSION TUBING WERE REMOVED, WE ATTACHED OUR OWN CONNECTOR AND THE IV WORKED WELL. IT TOOK A WHILE FOR US TO CALM THE PATIENT DOWN AND REPEAT THE SCAN. THIS DELAYED HIS CARE AND SPIKED HIS ANXIETY UNNECESSARILY AND DOUBLED THE AMOUNT OF RADIATION SINCE THE SCAN NEEDED TO BE REPEATED." NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7792510 ↗
• MalfunctionAug 17, 2018Disconnection

  IT WAS REPORTED THAT THE IV WAS SUCCESSFULLY TESTED WITH A SALINE FLUSH BY HAND AND WITH POWER INJECTOR. THE IV BECAME DISCONNECTED AFTER THE INJECTION OF CONTRAST, DURING THE CONTRAST CHASER USING THE POWER INJECTOR. THE STATLOCK AND TUBING WERE REMOVED AND A NEW CONNECTOR WAS ATTACHED BY THE CT TECH. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7792507 ↗
• MalfunctionJul 26, 2018Material Separation

  IT WAS REPORTED BY THE FACILITY THAT A NUMBER OF THEIR PATIENT'S HAD ONE OR MORE OF THE FOLLOWING ISSUES WITH THEIR IV KITS: THE IV SEPARATED DURING CONTRAST INJECTION. THE IV CONNECTIONS HAD TO BE COMPLETELY TAKEN APART (TAPE, IV EXTENSION, ETC.) AND REDONE WITH A NEW EXTENSION. A NEW IV HAD TO BE PLACED BECAUSE THE FIRST ONE COULD NOT "BE SAVED." THE FACILITY HAS STATED THAT THEY BELIEVE THIS HAPPENS BECAUSE THE DEVICE HUBS (EXTENSION SET W/ SMARTSITE) UNSCREWS FROM CATHETER HUB, CAUSING DISCONNECTION OF DEVICE. THEY NOTED THAT THIS OCCURS WITH OR WITHOUT THE SECUREMENT DEVICE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7724946 ↗
• MalfunctionJul 26, 2018Leak/Splash; Mechanical Problem

  IT WAS REPORTED THAT WHILE INJECTING CONTRAST DYE DURING A RADIOLOGY EXAM, THE CONTRAST DYE "SPRAYED." THE FACILITY BELIEVES THIS OCCURRED BECAUSE THE DEVICE BECAME DISCONNECTED BETWEEN THE HUBS, DESPITE THE TECH PHYSICALLY CHECKING THE EQUIPMENT PRIOR TO THE EXAM. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7724876 ↗