Skip to content

STATLOCK CV0321Recalls & reported problems

Bard Access Systems, Inc. · SL CV ULTRA DUAL PT TETHERED LOCKNG CAPS · Class 1

Adverse event reports
2
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741081576), received between Jan 31, 2020 and Jan 31, 2020 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Detachment of Device or Device Component2

Patient problems

  • No Consequences Or Impact To Patient2

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJan 31, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

    IT WAS REPORTED THAT "IT HAS OCCURRED FOR THE 2ND TIME IN TWO DIFFERENT PATIENTS THAT THE FIXATION MEMBER RELEASES FROM THE FIXATION PATCH. THE PATCH WAS ON THE PATIENT'S PHOTO, PLACED ON TUESDAY. THE PHOTO SHOWS WHAT THE NURSE FOUND FOUR DAYS LATER. PATIENT HAS NOT BEEN IN THE SHOWER WITH THE PATCH. THIS PATCH IS VERY IMPORTANT FOR THE FIXATION OF (NOT YET INGROWN) TUNNELED CENTRAL VENOUS CATHETERS. RELEASING HAS A SIGNIFICANT RISK OF DISLOCATION AND INFECTION." THIS REPORT ADDRESSES THE FIRST PATIENT.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9655065 ↗
  • MalfunctionJan 31, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

    IT WAS REPORTED THAT IT HAS OCCURRED FOR THE 2ND TIME IN TWO DIFFERENT PATIENTS THAT THE FIXATION MEMBER RELEASES FROM THE FIXATION PATCH. THE PATCH WAS ON THE PATIENT'S PHOTO, PLACED ON TUESDAY. THE PHOTO SHOWS WHAT THE NURSE FOUND FOUR DAYS LATER. PATIENT HAS NOT BEEN IN THE SHOWER WITH THE PATCH. THIS PATCH IS VERY IMPORTANT FOR THE FIXATION OF (NOT YET INGROWN) TUNNELED CENTRAL VENOUS CATHETERS. RELEASING HAS A SIGNIFICANT RISK OF DISLOCATION AND INFECTION. THIS REPORT ADDRESSES THE 2ND PATIENT.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9655049 ↗

Other DEVICE, INTRAVASCULAR CATHETER SECUREMENT devices

All DEVICE, INTRAVASCULAR CATHETER SECUREMENT devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.