contact detach 004182Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 05705244003293), received between Mar 28, 2019 and Apr 22, 2019 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (3 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 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryApr 22, 2019Material Twisted/Bent; Material Twisted/Bent

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. THE PATIENT'S MOTHER REPORTED THAT HER SON'S CANNULA WAS KINKED. REPORTEDLY, HE HAD HIGH BLOOD GLUCOSE LEVELS, WHICH HE SELF-TREATED WITH A BOLUS WITH THE PUMP. UPON ARRIVAL AT THE EMERGENCY, HIS BLOOD GLUCOSE LEVELS WERE IN THE RANGE OF 500-600 MG/DL AND HAD KETONES. HE STAYED THERE FOR TWO HOURS AND RECEIVED INTRAVENOUS INSULIN AND FLUIDS. THE HEALTH CARE PROFESSIONAL ASSESSED THE KETONE LEVELS AS DANGEROUS AND LIFE THREATENING, AS HE WAS STILL EXPERIENCED DIABETIC KETOACIDOSIS, SO THEY ADMITTED HIM TO THE INTENSIVE CARE UNIT. HE WAS GIVEN INTRAVENOUS INSULIN AND FLUIDS AS CORRECTIVE TREATMENT WHICH RESOLVED THE ISSUE. HE WAS ADMITTED FOR MORE THAN TWO DAYS AND THERE WAS NO PERMANENT DAMAGE TO THE PATIENT. UNOMEDICAL DO NOT SEE BENT/KINKING AS BEING RELATED TO HUMAN FACTORS, BUT RATHER AS A TRAINING ISSUE INCLUDING CORRECT CHOICES OF INSERTION SITES AND INFUSION SETS AND CANNULA LENGTH. FURTHERMORE, THE SOFT CANNULA IS A FLEXIBLE MATERIAL THAT DURING USE AND UPON REMOVAL CAN BEND SLIGHTLY. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis

  MAUDE report 8538410 ↗
• InjuryApr 22, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT PATIENT'S BLOOD GLUCOSE LEVEL INCREASED, AND THE SITE WAS REMOVED, NOTICED THAT THE CANNULA COULD NOT BE FOUND. A NEW SITE WAS INSERTED TO BRING DOWN PATIENT'S BLOOD GLUCOSE LEVEL. THE PATIENT WAS TAKEN TO THE EMERGENCY ROOM TO DETERMINE IF THE CANNULA WAS BROKEN OFF UNDER THE SKIN AND UNDERWENT X-RAYS SHOWING THE SITE WAS BROKEN OFF UNDER THE SKIN. PATIENT'S BLOOD GLUCOSE LEVEL WAS 326 MG/DL WHEN ARRIVED AT THE EMERGENCY ROOM AND RECEIVED TYLENOL VIA INTRAVENOUS ROUTE AS CORRECTIVE TREATMENT. THE EMERGENCY STAFF ATTEMPTED TO REMOVE THE CANNULA HOWEVER THEY WERE UNSUCCESSFUL. AFTER SPENDING 3 HOURS IN EMERGENCY ROOM THE PATIENT WAS SUBSEQUENTLY HOSPITALIZED AND RECEIVED ANTIBIOTICS AND FLUID VIA INTRAVENOUS ROUTE AS CORRECTIVE TREATMENT. PRIOR TO HOSPITALIZATION, THE PATIENT TOOK A BOLUS. THE CANNULA WAS SURGICALLY REMOVED, AND THE PATIENT RECEIVED 7 STITCHES. THE INFUSION SET WAS IN USE FOR 2 DAYS. THE PATIENT WAS HOSPITALIZED FOR 9 DAYS. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Tissue Damage

  MAUDE report 8535386 ↗
• InjuryApr 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 REPORTED THAT THE INFUSION SET SITE GOT UNCLIPPED BY ACCIDENT AND SHE EXPERIENCED DIABETES KETOACIDOSIS. SHE WAS ALSO SICK WITH BRONCHITIS AND HER BLOOD GLUCOSE LEVEL WAS IN LOW 400S MG/DL. THE PATIENT RECONNECTED IT AND TOOK A CORRECTIVE BOLUS, BUT HER BLOOD GLUCOSE LEVEL DID NOT COME DOWN AND SHE FELT BAD. SUBSEQUENTLY, SHE WAS HOSPITALIZED WHERE SHE RECEIVED DRIP VIA INTRAVENOUS ROUTE AND SALINE SOLUTION, WHICH RESOLVED THE ISSUE. THE INFUSION SET HAD BEEN IN USE FOR ONE AND HALF DAYS AND THERE WAS NO PERMANENT DAMAGE TO THE PATIENT. SHE WAS HOSPITALIZED FOR MORE THAN TWO DAYS. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis

  MAUDE report 8534880 ↗
• MalfunctionMar 28, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  (B)(4). EVENT OCCURRED IN THE UNITED STATES. THE PATIENT REPORTED THAT THE INFUSION SET'S TUBING BROKE AS IT GOT SNAGGED WHILE WALKING AROUND EARLIER ON THE DAY OF THIS REPORT. THE BLOOD GLUCOSE WAS REPORTED AS 390 MG/DL AND THE PATIENT SELF-TREATED WITH MANUAL INJECTION. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Hyperglycemia

  MAUDE report 8458929 ↗