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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: QUICK-SET® PARADIGM® QUICK-SET 60/9 PCC

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QUICK-SET® PARADIGM® QUICK-SET 60/9 PCC Back to Search Results
Lot Number 5203336
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Event Description
Unomedical reference number (b)(4). Event occurred in the united states. The patient reported, the infusion set tubing came out of the release site and detachment occurred at the quick connector. The patient stated, that the adhesive came off on one and the other couple, the tubing detached on several occasions and the patient had lost several reservoirs because of multiple infusion set issues. Reportedly, the set came out of her body when the patient was sleeping and sitting. The location was upper part of leg and the pump was worn on the hip area (left and right). There was no stress or pull on the tubing and the pump wasn't dropped with the set connected to the body. No further information available.
 
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Brand NameQUICK-SET® PARADIGM®
Type of DeviceQUICK-SET 60/9 PCC
Manufacturer Contact
aaholmvej 1-3
osted
lejre, 4320
MDR Report Key8202012
MDR Text Key131586810
Report Number3003442380-2018-00162
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
PMA/PMN Number
K160648
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Type of Report Initial
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/28/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/01/2020
Device Lot Number5203336
Was Device Available for Evaluation? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/08/2018
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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