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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: QUICK SET PARADIGM UNO QUICK-SET 60/9 SC1 MCAN

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QUICK SET PARADIGM UNO QUICK-SET 60/9 SC1 MCAN Back to Search Results
Lot Number UNKNOWN
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). On (b)(6) 2022, it was reported that the patient's infusion set's tubing detached at the quick release, and it was never inserted. The infusions were stored at room temperature in a cupboard. Moreover, there was no stress or pull on the tubing and the pump was not dropped with the set connected to their body. No further information available.
 
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Brand NameQUICK SET PARADIGM
Type of DeviceUNO QUICK-SET 60/9 SC1 MCAN
Manufacturer Contact
aaholmvej 1-3
osted
lejre, 4320
MDR Report Key13897150
MDR Text Key287904522
Report Number3003442380-2022-00432
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
Reporter Occupation
Type of Report Initial
Report Date 03/25/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/24/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No Answer Provided
Date Manufacturer Received03/09/2022
Was Device Evaluated by Manufacturer? No Answer Provided

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