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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: QUICK-SET PARADIGM UNO QUICK-SET 80/6 PCC MCAN

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QUICK-SET PARADIGM UNO QUICK-SET 80/6 PCC MCAN Back to Search Results
Model Number MMT-387600
Device Problems Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993)
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 24-dec-2020, the patient reported that the infusion set's tubing detached at the tubing connector. The patient stated that she had a blockage at the tubing connector, and she had to change the entire infusion set. Moreover, the patient had not used the infusion set. 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 patient's body. No further information available.
 
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Brand NameQUICK-SET PARADIGM
Type of DeviceUNO QUICK-SET 80/6 PCC MCAN
Manufacturer Contact
aaholmvej 1-3
osted
lejre, 4320
MDR Report Key11146162
MDR Text Key227093767
Report Number3003442380-2021-00108
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,Followup
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/11/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/01/2021
Device Model NumberMMT-387600
Device Lot Number5254081
Was Device Available for Evaluation? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/25/2021
Was Device Evaluated by Manufacturer? Yes
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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