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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: QUICK-SET® PARADIGM® QUICK-SET 110/9 PCC

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QUICK-SET® PARADIGM® QUICK-SET 110/9 PCC Back to Search Results
Lot Number 5217933
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 that her infusion set detached from the tubing connector cap and now her pump was missing. The pump was located on left hip connected to jeans and site location was left arm. The location of detachment was at p-cap and it occurred while going to pharmacy and restaurant. There was no stress or pull on the tubing and the patient did not remember whether the pump was dropped or not. No further information available.
 
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Brand NameQUICK-SET® PARADIGM®
Type of DeviceQUICK-SET 110/9 PCC
Manufacturer Contact
aaholmvej 1-3
osted
lejre, 4320
MDR Report Key8202021
MDR Text Key131587209
Report Number3003442380-2018-00181
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 Date01/01/2021
Device Lot Number5217933
Was Device Available for Evaluation? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/05/2018
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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