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Grip-Lok 3300MW-TA-3Recalls & reported problems

Tidi Products, LLC · Securement Device for Universal Fixation · Class 1

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00618125135455), received between Apr 24, 2023 and Apr 24, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Difficult or Delayed 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

Device problems

  • Difficult or Delayed Separation1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

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

  • MalfunctionApr 24, 2023Difficult or Delayed Separation; Difficult or Delayed Separation

    IT WAS REPORTED BY TELEFLEX ON 2023-03-21: "WHEN APPLYING THE DEVICE DURING REPLACEMENT, THE DEVICE GETS TORN. IT IS THEN UNUSABLE AND PROCEDURE CANNOT BE FINISHED WITH THIS PRODUCT." WHEN CONTACTED FOR ADDITIONAL INFORMATION ABOUT THE ALLEGED DEFECT, THE CUSTOMER REPLIED ON (B)(6) 2023: "ISSUES RELATED TO THE REMOVAL OF THE DEVICE WAS REPORTED, DURING THE REMOVAL THE ATTACHMENT SYSTEM HAD DIFFICULTY IN REMOVING, WHICH ALMOST LED TO THE REMOVAL OF THE PICC." BASED ON NEW INFORMATION PROVIDED, THIS COMPLAINT WAS DETERMINED TO BE REPORTABLE WITH THE FOLLOWING RATIONALE NOTED: DIFFICULTY REMOVING THE DEVICE MAY RESULT IN UNINTENDED REMOVAL OF THE MEDICAL LINES. THESE EVENTS MAY INTERRUPT PATIENT TREATMENT AND MAY CONTRIBUTE TO PATIENT INJURY. THEREFORE, THIS IS REPORTABLE. THERE HAVE BEEN NO INJURIES REPORTED THAT ARE ASSOCIATED WITH THIS COMPLAINT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16799344 ↗

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