Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: QUICK-SET® PARADIGM®; QUICK-SET 46/6 PCC
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

QUICK-SET® PARADIGM®; QUICK-SET 46/6 PCC Back to Search Results
Lot Number UNKNOWN
Medical Device Problem Code Material Twisted/Bent (2981)
Health Effect - Clinical Code Elevated ketones/Diabetic Ketoacidosis (2364)
Type of Reportable Event Serious Injury
Event or Problem Description
Unomedical reference number (b)(4).Event occurred in the united states.The patient reported that she had a bent cannula at ninety-degree angle, so she removed the cannula and self-treated herself with an injection, but her sugar still did not lower down therefore she went to the hospital.The site location was at the hip/towards the back and the issue occurred on the first day of using infusion set.The patient was hospitalized for high blood glucose level of 400 mg/dl at the time of hospitalization and diabetes ketoacidosis.She received treatment via intravenous route.According to the doctor the patient was medically fine but did not wanted her to be released.She was hospitalized for two days and was still in the hospital at the time of reporting.Unomedical do not see bent/kinking as being related to human factors, but rather as a training issue including correct choices of insertion sites and infusion sets and cannula length.Furthermore, the soft cannula is a flexible material that during use and upon removal can bend slightly.No further information available.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
QUICK-SET® PARADIGM®
Common Device Name
QUICK-SET 46/6 PCC
MDR Report Key8526697
Report Number3003442380-2019-01281
Device Sequence Number1303603
Product Code FPA
UDI-Device Identifier05705244006232
UDI-Public05705244006232
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? Yes
Is this a Product Problem Report? No
Operator of Device No Information
Device Lot NumberUNKNOWN
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 03/29/2019
Initial Report FDA Received Date04/18/2019
Patient Sequence Number1
-
-