contact detach 100-905-00Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 05705244005716), received between Mar 6, 2018 and Apr 22, 2019 — 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 18, 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.

• InjuryApr 22, 2019Infusion or Flow Problem; Infusion or Flow Problem

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. THE PATIENT'S DAUGHTER REPORTED AN OCCLUSION ISSUE AS PATIENT WAS TAKEN TO THE HOSPITAL. PATIENT WAS ADMITTED TO HOSPITAL WITH BLOOD GLUCOSE LEVEL OF 878 MG/DL AND DIAGNOSED WITH DIABETES KETOACIDOSIS. PATIENT HAD SYMPTOMS OF LETHARGY, INCOHERENCY AND VOMITING. THE PATIENT RECEIVED INSULIN VIA INJECTION, FLUIDS VIA INTRAVENOUS ROUTE AS CORRECTIVE TREATMENT AND THE INSERTION SITE WAS CHANGED. THE PATIENT WAS HOSPITALIZED FOR MORE THAN THREE DAYS. CURRENTLY, THE PATIENT WAS IN THE INTENSIVE CARE UNIT AND WAS BEING TREATED WITH AN INSULIN DRIP. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis

  MAUDE report 8535340 ↗
• MalfunctionApr 8, 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 TUBING ON THE INFUSION SET DISCONNECTED FROM THE PLASTIC CLIP. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8490449 ↗
• MalfunctionApr 7, 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 TWO OF THE INFUSION SETS BROKE AT THE NEEDLE. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8489932 ↗
• MalfunctionMar 29, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT THE QUICK RELEASE PORTION OF THE CONTACT DETACH FELL OFF PRIOR TO USE. PATIENT'S MOTHER STATED THAT IT LOOKED LIKE THERE WAS NO GLUE HOLDING THE QUICK RELEASE TO THE TUBING. UPON INVESTIGATION, IT WAS FOUND THAT THE TUBING WAS DETACHED FROM THE TUBING CONNECTOR DUE TO MISSING GLUE. FURTHERMORE, A DROP OF GLUE ON TUBING CONNECTOR WAS FOUND. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8463103 ↗
• MalfunctionJan 25, 2019Material Deformation; Material Deformation

  (B)(4). EVENT OCCURRED IN (B)(6). THE PATIENT REPORTED CRACKED/BROKEN TUBING. THE HOSE HAD GONE OFF AT THE BRACKET AS WELL. IN THE COMPLAINT INVESTIGATION, IT WAS FOUND THAT THE TUBING WAS DETACHED FROM THE TUBING CONNECTOR DUE TO MISSING GLUE. FURTHERMORE, THERE WAS EXCESS OF GLUE PRESENT WHERE THE TUBING WAS JOINED TO THE TUBING CONNECTOR. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8276824 ↗
• MalfunctionJan 7, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN (B)(6). THE PATIENT STATED THAT TUBING WAS BROKEN. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Hyperglycemia

  MAUDE report 8221046 ↗
• InjuryMar 6, 2018Break; Defective Device

  PROBLEM: THREE DIFFERENT NEEDLE PORTIONS OF CONTACT DETACH BROKE OFF IN OUR DAUGHTER. WHAT HAPPENED: OUR TYPE 1 DIABETIC DAUGHTER USES AN ANIMAS INSULIN PUMP, WITH CONTACT DETACH, AND A DEXCOM CGM. DURING THE FIRST INSTANCE, WE NOTICED BLOOD SUGAR LEVELS GREATER THAN 400 SUSTAINED FOR MULTIPLE HOURS. AFTER MULTIPLE ATTEMPTS TO ADMINISTER INSULIN AND NOT SEEING ANY CHANGE IN BLOOD SUGAR LEVELS, WE ENDED UP REPLACING AND REINSERTING ALL OF THE PUMP STUFF. IT WAS THEN THAT WE DISCOVERED THAT THE NEEDLE THAT WAS INSERTED IN HER TO DELIVER INSULIN HAD BROKEN OFF RESULTING IN NO OR MINIMAL INSULIN DELIVERY. WE CONTACTED HER ENDOCRINOLOGIST, AND ANIMAS. SINCE ANIMAS IS CLOSING, THE REPRESENTATIVE THAT WE SPOKE SAID THEY WERE FROM MEDTRONIC. WE ENDED UP NEEDING A SURGICAL CONSULT, RESULTING IN THE DECISION TO LEAVE THE EMBEDDED NEEDLE UNTIL IT CAUSES INFECTION. THE SECOND INSTANCE OF THE NEEDLE BREAKING HAPPENED DURING A RESET OF HER CGM. SHE PRESENTED WITH BLOOD SUGAR LEVELS OF OVER 550 FOR OVER 15 HOURS, FROM AFTER DINNER TO WHEN WE WOKE HER UP IN THE MORNING. WE AGAIN HAD MULTIPLE ATTEMPTS TO BRING HER BLOOD SUGAR DOWN, BUT WITHOUT THE AID OF A CGM WE ASSUMED THAT THE AMOUNT OF INSULIN

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7320606 ↗