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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SURE-T® PARADIGM®; CONTACT DETACH G29 60/8 PCC
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SURE-T® PARADIGM®; CONTACT DETACH G29 60/8 PCC Back to Search Results
Lot Number 5188330
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).The patient reported that the infusion set's tubing detached from the quick release part during normal use.No further information available.
 
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Brand Name
SURE-T® PARADIGM®
Common Device Name
CONTACT DETACH G29 60/8 PCC
MDR Report Key8963570
Report Number3003442380-2019-01727
Device Sequence Number2099578
Product Code FPA
UDI-Device Identifier05705244005792
UDI-Public05705244005792
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 Date04/01/2020
Device Lot Number5188330
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 01/29/2018
Initial Report FDA Received Date09/05/2019
Patient Sequence Number1
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