medical action industries 77993DRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10809160400890), received between Apr 13, 2026 and Apr 13, 2026 — classified as 1 malfunction.

The most frequently reported specific device problem is “Accessory Incompatible” (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 18, 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.

• MalfunctionApr 13, 2026Accessory Incompatible

  DURING A PICC LINE DRESSING CHANGE, THE PRIMARY NURSE ENCOUNTERED AN ISSUE WITH THE STATLOCK DEVICE WHEN THE PRONGS BECAME STUCK, RENDERING IT UNUSABLE. AS A RESULT, THE NURSE COMPLETED THE DRESSING WITHOUT THE STATLOCK, OBTAINED A NEW DRESSING KIT FROM ANOTHER UNIT DUE TO LACK OF SUPPLY IN THE CICU, AND REDRESSED THE LINE. THE REPLACEMENT KIT ALSO CONTAINED A STATLOCK DEVICE THAT WAS DIFFICULT TO OPERATE, WITH DOORS THAT WERE HARD TO CLOSE AND PRONGS THAT WERE CHALLENGING TO ADJUST TO FIT THE PICC LINE WINGS. DURING THE SECOND DRESSING CHANGE THE STATLOCK WAS DIFFICULT TO USE AND MANIPULATE. INITIALLY SUSPECTED TO BE A LOT-SPECIFIC ISSUE, SIMILAR DIFFICULTIES WERE OBSERVED IN STATLOCK DEVICES FROM TWO DIFFERENT PICC DRESSING KIT LOT NUMBERS (346388 AND 343567). THERE WAS A REPORTED 60 MIN DELAY IN COMPLETION OF PROCEDURE; HOWEVER, THERE WAS NO PATIENT ADVERSE EFFECTS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24865713 ↗