TruSteel™ 1000289Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 05705244014879), received between Dec 21, 2018 and Jan 10, 2025 — classified as 2 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (4 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 16, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 10, 2025Material Deformation; Material Deformation

  TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.

  Patient problems: Hyperglycemia

  MAUDE report 21122164 ↗
• MalfunctionJul 1, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  (B)(4). EVENT OCCURRED IN THE UNITED STATES IT WAS REPORTED THAT A CHILD PATIENT'S INFUSION SET'S TUBING HAD SNAPPED FROM THE INFUSION SET. HER BLOOD GLUCOSE LEVEL WAS 107 MG/DL AT THE TIME OF THIS EVENT. THEY DID NOT NOTICE ANY DAMAGE WHEN THE PACKAGE WAS FIRST OPENED. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10216240 ↗
• MalfunctionMay 22, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. THE PATIENT'S MOTHER REPORTED THAT IN ONE OF THE INFUSION SETS, THE TUBING CAME UNGLUED AT THE SITE CONNECTION. THE PATIENT'S BLOOD GLUCOSE LEVEL WAS 215 MG/DL AT THE TIME OF THIS EVENT. THE PATIENT DID NOT NOTICE ANY DAMAGE WHEN THE PACKAGE WAS FIRST OPENED. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8630556 ↗
• InjuryApr 18, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT THE PATIENT WAS HOSPITALIZED FOR DIABETES KETOACIDOSIS AND INFECTION AROUND SITE ON UPPER LEFT THIGH DUE TO INFUSION SET. PATIENT'S BLOOD GLUCOSE LEVEL WAS IN THE 300S MG/DL. THE INFUSION SET HAD BEEN IN USE FOR LESS THAN ONE DAY AND REVERTED TO MULTIPLE DAILY INJECTIONS DUE TO INFECTION/HOSPITALIZATION. THE PATIENT WAS HOSPITALIZED FOR FIVE DAYS. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis

  MAUDE report 8526590 ↗
• InjuryMar 26, 2019Material Twisted/Bent; Material Twisted/Bent

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. THE PATIENT REPORTED THAT THE INFUSION SET WAS KINKED AND STRESSED. PRIOR TO HOSPITALIZATION, HE SELF-TREATED WITH A CORRECTION BOLUS. HIS BLOOD GLUCOSE WAS 1200 MG/DL AND HE EXPERIENCED DIABETIC KETOACIDOSIS. DURING THE STAY IN THE HOSPITAL, HE RECEIVED ANTIBIOTICS, OXYGEN AND DOME UNSPECIFIED DRUG VIA INTRAVENOUS DRIP WHICH RESOLVED THE ISSUE. HE WAS HOSPITALIZED FOR NINE DAYS. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis

  MAUDE report 8450831 ↗
• MalfunctionFeb 1, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. THE PATIENT REPORTED THAT HER INFUSION SET TUBING SNAPPED RIGHT ABOVE THE CONNECTER PIECE WHILE SHE WAS SLEEPING ABOUT A WEEK BEFORE THIS REPORT. HER BLOOD GLUCOSE LEVEL WAS 300 MG/DL AT THE TIME OF THIS EVENT. SHE DID NOT NOTICE ANY DAMAGE WHEN THE PACKAGE WAS FIRST OPENED. SHE SUCCESSFULLY CHANGED OUT INFUSION SET AND RESUMED INSULIN ON PUMP. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Hyperglycemia

  MAUDE report 8295555 ↗
• MalfunctionDec 21, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  (B)(4). EVENT OCCURRED IN THE UNITED STATES. THE PATIENT'S MOTHER REPORTED, HER SON'S INFUSION SET TUBING SEPARATED FROM THE CONNECTOR PIECE AT TWO DIFFERENT TIMES. THE ISSUE RESOLVED BY INSERTING A NEW INFUSION SET AND RESUMING INSULIN. AFTER FIRST DETACHMENT, THE PATIENT BLOOD GLUCOSE LEVEL WAS 189 MG/DL. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8188572 ↗