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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: QUICK-SET® PARADIGM®; QUICK-SET 80/6 PCC
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QUICK-SET® PARADIGM®; QUICK-SET 80/6 PCC Back to Search Results
Lot Number 5233470
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 the united states.The patient reported that in two infusion sets, the tubing that went into the plastic piece, which further went into the patient broke off.The location of detachment was at the quick release.This issue occurred for the first time while the patient was sleeping and the second time, when the patient was just out and about.The site location was patient's left and right leg, respectively.The infusion had been in use for two days.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 the patient's body.Upon investigation of the returned used devices (2 tubes), it was found that the tubes were detached from the tubing- tubing connectors.No further information available.
 
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Brand Name
QUICK-SET® PARADIGM®
Common Device Name
QUICK-SET 80/6 PCC
MDR Report Key8806283
Report Number3003442380-2019-01635
Device Sequence Number10842884
Product Code FPA
UDI-Device Identifier05705244006492
UDI-Public05705244006492
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 Date08/01/2021
Device Lot Number5233470
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 04/18/2019
Initial Report FDA Received Date07/19/2019
Patient Sequence Number1
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