SecurAcath 5FRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00865382000228), received between Jul 31, 2017 and Jul 16, 2020 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Device Issue” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 16, 2020No Apparent Adverse Event; No Apparent Adverse Event

  A TRIPLE LUMEN BARD POWERPICC WAS PLACED ON (B)(6) AND SECURED WITH A 5F SECURACATH IN THE RIGHT BRACHIAL VEIN FOR IV FLUIDS ON A COVID POSITIVE PATIENT. ON (B)(6) THE GREY LUMEN WAS FOUND TO BE LEAKING NEAR OR AT THE SECURACATH. THE CATHETER WAS REPLACED BY OVERWIRE WITHOUT DIFFICULTY. DRESSING CHANGES OCCURRED ON (B)(6) (DUE TO OLD BLOOD) AND ON (B)(6) (DUE TO IT BEING MOIST). FLOW WAS NOTED TO BE SLUGGISH ON BOTH LUMENS FROM (B)(6) THROUGH (B)(6). THE USER FACILITY FDA REPORT NUMBER PROVIDED WAS MW5095271.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10284180 ↗
• MalfunctionJun 12, 2019No Apparent Adverse Event; No Apparent Adverse Event

  (B)(6) MEDICAL CLINICAL EDUCATOR RECEIVED A CALL ABOUT A NURSE WHO WAS PLACING A 5F SECURACATH DEVICE ON AN ARROW 5.5F MIDLINE CATHETER AND WAS UNABLE TO SNAP THE SECURACATH BASE AND COVER TOGETHER. SHE OPENED A NEW ONE THAT WORKED WITHOUT ANY PROBLEMS AND SAVED THAT DEVICE THAT DID NOT SNAP TOGETHER. THE DEVICE WAS RETURNED TO (B)(6) MEDICAL AND WAS ABLE TO BE SNAPPED ON TO A 5.5F ARROW MIDLINE CATHETER WITHOUT ISSUE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8693483 ↗
• MalfunctionJul 31, 2017Device Issue; Material Integrity Problem; Physical Property Issue; Torn Material; Device Issue; Material Integrity Problem; Physical Property Issue; Torn Material

  (B)(6) 2017: (B)(4) DISTRIBUTOR MEDICAL SPECIALTIES (B)(4) WAS NOTIFIED BY A CLINICAL NURSE CONSULTANT OF AN INCIDENT INVOLVING SECURACATH. A SECURACATH HAD BEEN PLACED WITH A PICC ON (B)(6) 2017. ON (B)(6) 2017, IT WAS OBSERVED THAT THE SECURACATH HAD COME OUT WHILE STILL ATTACHED TO THE PICC WHICH HAD MIGRATED 5CM. ON INSPECTION BY THE PICC TEAM, THEY OBSERVED THE NITINOL "FOOT" ON ONE SIDE OF THE SECURACATH HAD SEPARATED FROM THE REST OF THE SECURACATH AND WAS STILL UNDER THE SKIN, THE "FOOT" COULD BE FELT JUST BENEATH THE SKIN, AND WAS CAUSING THE PATIENT NO DISCOMFORT. THE SIZE OF THE "FOOT" IS .194 INCHES (4.9 MM). ON (B)(6) 2017, THE PATIENT RETURNED TO THE HOSPITAL SO THAT A NEW PICC LINE COULD BE INSERTED, WHICH WENT WELL. THE SITE WHERE THE "FOOT" OF THE SECURACATH HAS SEPARATED WAS ASSESSED AND HAD HEALED WITHOUT PROBLEM. IT WAS DECIDED TO NOT ATTEMPT REMOVAL AT THIS TIME AS THE PATIENT WAS STARTING A CHEMOTHERAPY CYCLE THE SAME DAY. THE FOOT OF THE SECURACATH WAS CAUSING THE PATIENT NO DISCOMFORT. THE PICC TEAM WAS OF THE OPINION THAT COMPLETE REMOVAL WOULD NOT BE DIFFICULT SHOULD THE PATIENT WANT TO PROCEED.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 6754559 ↗