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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SURE-T PARADIGM UNO CONTACT DETACH G29 80/8 SC1 MIMX

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SURE-T PARADIGM UNO CONTACT DETACH G29 80/8 SC1 MIMX Back to Search Results
Model Number MMT-876A
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event Description
Unomedical reference number (b)(4). Event occurred in (b)(6). It was reported that on (b)(6) 2021, the patient's infusion set's tubing detached at the tubing connector while sleeping. The site location was the patient's abdomen, and the pump was on the right side. The infusion had been 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. Further, there was no stress or pull on the tubing, and the pump was not dropped with the set connected to the body. No further information available.
 
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Brand NameSURE-T PARADIGM
Type of DeviceUNO CONTACT DETACH G29 80/8 SC1 MIMX
MDR Report Key12597781
MDR Text Key275927501
Report Number3003442380-2021-00557
Device Sequence Number1
Product Code FPA
Combination Product (y/n)Y
PMA/PMN Number
K160648
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Type of Report Initial
Report Date 10/08/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/08/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMMT-876A
Device Lot Number5325105
Was Device Available for Evaluation? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/29/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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