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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SURE-T® PARADIGM®; CONTACT DETACH G29 80/8 PCC
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SURE-T® PARADIGM®; CONTACT DETACH G29 80/8 PCC Back to Search Results
Lot Number UNKNOWN
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
(b)(4).Event occurred in united states.The patient stated, he noticed that the tubing had come off the quick release connector and it looked like that the plastic was molded incorrectly.The patient started using infusion one day prior only.No further information available.
 
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Brand Name
SURE-T® PARADIGM®
Common Device Name
CONTACT DETACH G29 80/8 PCC
MDR Report Key8172564
Report Number3003442380-2018-00100
Device Sequence Number2025639
Product Code FPA
UDI-Device Identifier05705244006072
UDI-Public05705244006072
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 Lot NumberUNKNOWN
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 11/19/2018
Initial Report FDA Received Date12/17/2018
Patient Sequence Number1
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