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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: QUICK-SET® PARADIGM®; QUICK-SET 60/6 PCC
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QUICK-SET® PARADIGM®; QUICK-SET 60/6 PCC Back to Search Results
Lot Number 5189471
Medical Device Problem Code Detachment of Device or Device Component (2907)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event Malfunction
Event or Problem Description
Unomedical reference number (b)(4).Event occurred in (b)(6).It was reported that while sleeping, her two of the infusion set's tubing got detached at the quick release.This issue happened last night and 2 nights ago.No further information available.
 
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Brand Name
QUICK-SET® PARADIGM®
Common Device Name
QUICK-SET 60/6 PCC
MDR Report Key8494715
Report Number3003442380-2019-01048
Device Sequence Number1780893
Product Code FPA
UDI-Device Identifier05705244006317
UDI-Public05705244006317
Combination Product (Y/N)N
PMA/510(K) Number
K160648
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source distributor
Initial Reporter Occupation Other
Type of Report Initial
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device No Information
Device Expiration Date09/01/2020
Device Lot Number5189471
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 04/19/2018
Initial Report FDA Received Date04/09/2019
Patient Sequence Number1
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