Sure-T® Paradigm® MMT-876Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 05705244006072), received between Dec 17, 2018 and Aug 19, 2020 — classified as 22 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (22 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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 19, 2020Detachment 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 THE PATIENT'S INFUSION SET'S TUBING DETACHED AT THE SITE CONNECTOR. THE SITE LOCATION WAS HIS RIGHT SIDE OF ABDOMEN AND THE PUMP WAS ALSO LOCATED ON THE RIGHT SIDE OF ABDOMEN. MOREOVER, THE INFUSION HAD BEEN IN USE FOR ONE DAY. REPORTEDLY, THE INFUSIONS WERE STORED IN NORMAL AIRCONDITIONED SPACE. THERE WAS NOT ANY STRESS OR PULL ON THE TUBING AND THE PUMP WAS NOT DROPPED WITH THE SET CONNECTED TO PATIENT'S BODY. CURRENTLY, (ON THE DAY OF THIS REPORT (B)(6) 2020), THE PATIENT'S BLOOD GLUCOSE LEVEL WAS 280 MG/DL. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Hyperglycemia

  MAUDE report 10424489 ↗
• MalfunctionNov 20, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  ON 18-DEC-2019: FOLLOW UP INFORMATION WAS SUBMITTED BECAUSE RESULT OF COMPLAINT INVESTIGATION OF THE RETURNED USED DEVICE (1 SET) SHOWED THAT THE TUBING WAS DETACHED FROM THE TUBING CONNECTOR. BASED ON THE RESULT: METHOD, RESULT AND CONCLUSION CODES WERE UPDATED. UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. THE PATIENT REPORTED THAT IN THE MORNING OF (B)(6) 2019, SHE RECEIVED AN ALERT FOR HIGH BLOOD GLUCOSE LEVEL AND THEN SHE NOTICED THAT THE INFUSION SET'S TUBING HAD DETACHED FROM THE TUBING CONNECTOR, WHILE SLEEPING. THE SITE LOCATION WAS THE BACK OF HER ARM AND THE PUMP WAS IN THE SIDE POCKET. THE INFUSION HAD BEEN IN USED FOR ONE DAY. THE INFUSIONS WERE NOT STORED, OR USED, IN A PLACE WHERE THEY MIGHT HAVE BEEN EXPOSED TO EXTREME TEMPERATURES AND HUMIDITY. THERE WAS NO STRESS OR PULL ON THE TUBING AND THE PUMP WAS NOT DROPPED WITH THE SET CONNECTED TO THE PATIENT'S BODY. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9345851 ↗
• MalfunctionOct 21, 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'S TUBING FELL OUT, AS IT DETACHED FROM THE QUICK RELEASE WHILE SHE WAS SLEEPING, DURING THE NIGHT. REPORTEDLY, SHE WOKE UP AT 2 AM WITH A LOW BLOOD GLUCOSE LEVEL BUT AT 4 AM HER BLOOD GLUCOSE LEVEL WAS HIGH. THE SITE LOCATION WAS HER UPPER BUTTOCKS AND THE PUMP WAS LOCATED BESIDE THE BED. THE INFUSION HAD BEEN IN USE FOR ONE DAY. THERE WAS NO STRESS OR PULL ON THE TUBING AND THE PUMP WAS NOT DROPPED WITH THE SET CONNECTED TO HER BODY. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9212710 ↗
• MalfunctionOct 9, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  ON 18-DEC-2019: FOLLOW UP INFORMATION WAS SUBMITTED BECAUSE RESULT OF COMPLAINT INVESTIGATION OF THE RETURNED USED DEVICE (1 SET) SHOWED THAT THE TUBING HAD DETACHED AT BASE CONNECTOR. BASED ON THE RESULT: METHOD, RESULT AND CONCLUSION CODES WERE UPDATED. UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. THE PATIENT REPORTED THAT THE INFUSION SET WAS DAMAGED OFF IN THE PACKAGING, AS THE INFUSION SET'S TUBING WAS DETACHED AND IT WAS NEVER USED. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9171302 ↗
• MalfunctionJun 28, 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 IN THE MORNING OF THIS REPORT, THE INFUSION SET'S TUBING DETACHED AND SLID OUT OF THE QUICK RELEASE. THE SITE LOCATION WAS PATIENT'S ABDOMEN AND THE PUMP WAS LOCATED ON THE BELT LINE. THE INFUSION WAS USED FOR A COUPLE OF DAYS. THE INFUSIONS WERE NOT STORED, OR USED, IN A PLACE WHERE THEY MIGHT HAVE BEEN EXPOSED TO EXTREME TEMPERATURES AND HUMIDITY. THERE WAS NO STRESS OR PULL ON THE TUBING AND THE PUMP WAS NOT DROPPED WITH THE SET CONNECTED TO THE PATIENT'S BODY. UPON INVESTIGATION OF THE RETURNED USED DEVICE, IT WAS FOUND THAT THE TUBING WAS DETACHED FROM THE TUBING- TUBING CONNECTOR. THE PATIENT EXPERIENCED THE SAME EVENT TWICE AND THE SECOND EVENT HAS BEEN REPORTED IN 3003442380-2019-01571. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8743357 ↗
• MalfunctionJun 28, 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 THE PATIENT'S INFUSION SET'S TUBING CAME OUT OF THE CONNECTION POINT AND DETACHED AT THE QUICK RELEASE WHILE THE PATIENT WAS SITTING. IT WAS SIMPLY HANGING AND THEREAFTER, THE PATIENT REPLACED IT. THE SITE LOCATION WAS PATIENT'S ABDOMEN AND THE PUMP WAS LOCATED ON THE BELT LINE. THE INFUSION WAS USED FOR A COUPLE OF DAYS. THE INFUSIONS WERE NOT STORED, OR USED, IN A PLACE WHERE THEY MIGHT HAVE BEEN EXPOSED TO EXTREME TEMPERATURES AND HUMIDITY. THERE WAS NO STRESS OR PULL ON THE TUBING AND THE PUMP WAS NOT DROPPED WITH THE SET CONNECTED TO THE PATIENT'S BODY. UPON INVESTIGATION OF THE RETURNED USED DEVICE, IT WAS FOUND THAT THE TUBING WAS DETACHED FROM THE TUBING- TUBING CONNECTOR. THE PATIENT EXPERIENCED THE SAME EVENT TWICE AND THE SECOND EVENT HAS BEEN REPORTED IN 3003442380-2019-01578. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8743146 ↗
• MalfunctionJun 10, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN (B)(6). IT WAS REPORTED THAT THE INFUSION SET'S TUBING DETACHED AT THE QUICK RELEASE. THE PATIENT OBSERVED INSULIN COMING OUT OF THE TUBING ABOUT TWO HOURS AFTER SET CHANGE. THIS ISSUE OCCURRED WITH ONE SET. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8681529 ↗
• MalfunctionApr 26, 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 TUBING CAME APART, AT THE TUBING CONNECTOR QUICK RELEASE CAP WHILE FILLING THE TUBING DURING A SET CHANGE. THE SITE LOCATION WAS AT THE RIGHT ABDOMEN. THE PATIENT WAS IN THE PROCESS OF CHANGING OUT THE SET, WHEN IT WAS OBSERVED THAT THE CAP PULLED OFF AT THE QUICK RELEASE CONNECTOR/ATTACHMENT. REPORTEDLY, THE INFUSIONS WERE STORED IN THE HOUSE IN A ROOM WHERE SHE REPLACED THE INFUSION SETS AND THE TEMPERATURE RANGED FROM 68-72 ºF. THE PATIENT WAS PULLING THE COVER OFF, TO INSERT INTO THE SHORTER PIECE AND THIS WAS WHEN THE TUBING CAME OUT. THERE WAS NO STRESS OR PULL ON THE TUBING AND THE PUMP WAS NOT DROPPED WITH THE SET CONNECTED TO THE PATIENT'S BODY. IN THE INVESTIGATION, IT WAS FOUND THAT THE GLUE WAS MISSING FROM THE TUBING CONNECTOR (GLUE WAS MISPLACED ON THE TUBING CONNECTOR). NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8553609 ↗
• MalfunctionApr 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 TUBING DISCONNECTED FROM THE INFUSION SET WHEN OPENED THE PACKAGE AT THE QUICK RELEASE. REPORTEDLY, THE INFUSIONS WERE NOT STORED, OR USED, IN A PLACE WHERE THEY MIGHT HAVE BEEN EXPOSED TO EXTREME TEMPERATURES AND HUMIDITY. THERE WAS NO STRESS OR PULL ON THE TUBING AND THE PUMP WAS NOT DROPPED WITH THE SET CONNECTED TO THE PATIENT'S BODY. IN THE INVESTIGATION IT WAS FOUND THAT THE GLUE WAS MISSING FROM THE TUBING CONNECTOR (GLUE WAS MISPLACED ON THE TUBING CONNECTOR). NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8534819 ↗
• MalfunctionApr 11, 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 THE INFUSION SET FELL OFF WHILE THE PATIENT WAS USING IT ON HER LEG. THE BLOOD GLUCOSE LEVEL WAS 300-400 MG/DL AND THE SITE LOCATION WAS AT THE UPPER ABDOMEN. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8502784 ↗
• MalfunctionApr 9, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  (B)(4). EVENT OCCURRED IN THE UNITED STATES. THE PATIENT REPORTED THAT IN THE MORNING OF THIS REPORT, TUBING HAD BECOME DETACHED AT THE BASE OF THE CONNECTOR WHILE SLEEPING AND THE INSULIN WAS ENDING UP IN THE BED SHEETS UNDETECTED. PATIENT'S BLOOD GLUCOSE LEVEL WAS 422 MG/DL AT THE TIME OF EVENT AND SERUM GLUCOSE LEVEL WAS 205 MG/DL BEFORE THE ISSUE OCCURRED. THE PATIENT INJECTED 12 UNITS OF INSULIN VIA SYRINGE AND STARTED GIVING MANUAL BOLUSES AFTER CHANGING OUT THE SET CONNECTOR. BLOOD GLUCOSE LEVEL REMAINED ABOVE 300 MG/DL FOR THE NEXT SEVERAL HOURS, RANGING FROM A HIGH OF 434 MG/DL AND THEN FINALLY BELOW 275 MG/DL. THE INFUSION HAD BEEN IN USE FOR LESS THAN 24 HOURS. REPORTEDLY, THE PATIENT WAS UNCERTAIN WHETHER THERE WAS STRESS OR PULL ON THE TUBING AND WAS ALSO UNCERTAIN WHETHER THE PUMP WAS DROPPED WITH THE SET CONNECTED TO THE PATIENT'S BODY. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Hyperglycemia

  MAUDE report 8495433 ↗
• MalfunctionApr 9, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN (B)(6). THE PATIENT'S FATHER REPORTED DETACHMENT AS THE PATIENT WAS CONNECTING TUBING TO THE SET AND TUBING DETACHED FROM THE PART CONTAINING NEEDLE. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8494389 ↗
• MalfunctionApr 9, 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 IN THE PROCESS OF INSERTING A SET IT GOT PULLED OUT OF THE CONNECTOR, TUBING CAME OFF FROM THE HEAD AND WAS IN THE HAND. THE SITE LOCATION WAS 5 INCHES BELOW BELLY BUTTON AND THE PUMP WAS LAYING ON THE TABLE. THE INFUSION WAS NOT IN USE AS THE ISSUE OCCURRED WHILE CHANGING THE SET. REPORTEDLY, THE INFUSIONS WERE STORED IN THE KITCHEN. THERE WAS NO STRESS OR PULL ON THE TUBING AND THE PUMP WAS NOT DROPPED WITH THE SET CONNECTED TO THE PATIENT'S BODY. IN THE INVESTIGATION IT WAS FOUND THAT THE GLUE IN THE TUBING CONNECTOR WAS MISSING. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8494314 ↗
• 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 INFUSION SET'S TUBING DETACHED AT THE QUICK RELEASE. REPORTEDLY, WHEN SHE OPENED THE PACKET ON THE INFUSION SET, IT WAS FOUND THAT IT WAS DETACHED COMPLETELY FROM THE LINE AND IT WAS UNUSABLE, AND SHE DISCARDED THAT SET. THE BLOOD GLUCOSE WAS REPORTED TO BE HIGH. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8494253 ↗
• MalfunctionApr 2, 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 TUBING FELL OFF WHEN THE PATIENT CHANGED INFUSION SET ABOUT A MONTH AGO. THE SITE WAS AT THE RIGHT ABDOMEN AND THE PUMP WAS ON HIS LAP AT THE TIME. HE WAS JUST PUTTING THE SET WHEN THE ISSUE OCCURRED. REPORTEDLY, THE INFUSIONS WERE STORED IN HIS HOUSE. THERE WAS NO STRESS OR PULL ON THE TUBING AND THE PUMP WAS NOT DROPPED WITH THE SET CONNECTED TO THE PATIENT'S BODY. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8472260 ↗
• MalfunctionMar 31, 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 SHE WAS JUST SLEEPING WHEN SHE WOKE UP AND WENT TO THE BATHROOM WHERE SHE NOTICED THAT THE SET RELEASE WAS DETACHED FROM THE SET CONNECTOR. THE SITE LOCATION WAS PATIENT'S UPPER ABDOMEN, ALIGNED WITH THE NAVEL AND THE PUMP WAS CLIPPED ON TO THE GOWN. THE INFUSION HAD BEEN IN USE FOR TWO DAYS AND THE INFUSIONS WERE NOT STORED, OR USED, IN A PLACE WHERE THEY MIGHT HAVE BEEN EXPOSED TO EXTREME TEMPERATURES AND HUMIDITY. THERE WAS NO STRESS OR PULL ON THE TUBING AND THE PUMP WAS NOT DROPPED WITH THE SET CONNECTED TO THE PATIENT'S BODY. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Inflammation

  MAUDE report 8468000 ↗
• MalfunctionFeb 15, 2019Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  ON 08-NOV-2019: FOLLOW UP INFORMATION WAS SUBMITTED BECAUSE RESULT OF COMPLAINT INVESTIGATION OF THE RETURNED USED DEVICE (1 SET) SHOWED THAT THE ALL THE TEST WERE WITHIN SPECIFICATIONS. BASED ON THE RESULT: DEVICE, METHOD, RESULT AND CONCLUSION CODES WERE UPDATED. UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. THE PATIENT STATED THAT THE NEEDLE GOT PULLED OUT OF THE BODY ACCIDENTLY AND THE PATIENT HAD TO STICK THE NEEDLE BACK IN. IT WAS ALSO REPORTED THAT THE INFUSION SET TUBING CAME APART WHILE CHANGING SHIRTS. THE SITE LOCATION WAS ON THE PATIENT'S RIGHT SIDE AND THE PUMP WAS WORN ON THE PATIENT'S HIP ON RIGHT SIDE OR CENTER OF THE BODY. THE INFUSIONS WERE NOT STORED, OR USED, IN A PLACE WHERE THEY MIGHT HAVE BEEN EXPOSED TO EXTREME TEMPERATURES AND HUMIDITY. THE PATIENT WAS UNSURE WHETHER THERE WAS STRESS OR PULL ON THE TUBING AND THE PUMP WAS NOT DROPPED WITH THE SET CONNECTED TO THE PATIENT'S BODY. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8342385 ↗
• MalfunctionJan 21, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN (B)(6). THE PATIENT REPORTED THAT, THE INFUSION SET WAS GETTING LOOSE AT THE QUICK RELEASE AND IT WAS NOTICED WHILE GOING TO THE TOILET NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8265857 ↗
• MalfunctionJan 19, 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, TUBING HAD DETACHED FROM THE QUICK RELEASE AND BLOOD GLUCOSE LEVEL WAS 127 MG/DL. SHE USED A WALKER AND WHEN SHE STOOD UP THE TUBING FELL DOWN IN FRONT OF HER JEANS. THE INFUSION WAS BEING USED FROM 2 DAYS. THE INFUSION SITE WAS AT RIGHT ABDOMEN AND THE PUMP WAS WORN ON THE SAME SIDE. REPORTEDLY, THE INFUSIONS WERE STORED IN THE BATHROOM. THERE WAS NO STRESS OR PULL ON THE TUBING AND THE PUMP WAS NOT DROPPED WITH THE SET CONNECTED TO THE PATIENT'S BODY. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8263051 ↗
• MalfunctionJan 19, 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 WHILE HE WAS CHANGING THE INFUSION SET THE TUBING PULLED OUT OF THE SET. REPORTEDLY, IN COMPLAINT INVESTIGATION, IT WAS FOUND THAT THE GLUE WAS MISSING FROM THE TUBING CONNECTOR. THE INFUSION SET INSERTION SITE WAS AT THE RIGHT ABDOMEN AND THE PUMP WAS WORN ON THE RIGHT SIDE. THE ISSUE OCCURRED WHILE THE PATIENT WAS CHANGING SET. THE INFUSIONS WERE NOT STORED IN EXTREME HEAT. THE PATIENT REPORTED THERE WAS NO STRESS OR PULL ON THE TUBING AND THE PUMP WAS NOT DROPPED WITH THE SET CONNECTED TO THE PATIENT'S BODY. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8263045 ↗
• MalfunctionJan 15, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN (B)(6). THE PATIENT'S MOTHER REPORTED THAT TUBE OF HER DAUGHTER'S INFUSION SET HAD BROKEN SEVERAL TIMES. IT BROKE WHERE THE TUBE CONNECTS TO THE INFUSION SET. SHE CHANGES THE INFUSION SET EVERY 2 DAYS. THE INFUSION SET WAS REPLACED. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8247002 ↗
• MalfunctionDec 17, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  (B)(4). EVENT OCCURRED IN UNITED STATES. THE PATIENT STATED, HE NOTICED THAT THE TUBING HAD COME OFF THE QUICK RELEASE CONNECTOR AND IT LOOKED LIKE THAT THE PLASTIC WAS MOLDED INCORRECTLY. THE PATIENT STARTED USING INFUSION ONE DAY PRIOR ONLY. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8172564 ↗