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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 5199713
Medical Device Problem Code Detachment of Device or Device Component (2907)
Health Effect - Clinical Code Inflammation (1932)
Type of Reportable Event Malfunction
Event or Problem Description
Unomedical reference number (b)(4).Event occurred in the united states.The patient reported that she was just sleeping when she woke up and went to the bathroom where she noticed that the set release was detached from the set connector.The site location was patient's upper abdomen, aligned with the navel and the pump was clipped on to the gown.The infusion had been in use for two days and 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.No further information available.
 
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Brand Name
SURE-T® PARADIGM®
Common Device Name
CONTACT DETACH G29 80/8 PCC
MDR Report Key8468000
Report Number3003442380-2019-00842
Device Sequence Number1571395
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 Expiration Date07/01/2020
Device Lot Number5199713
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 12/11/2017
Initial Report FDA Received Date03/31/2019
Patient Sequence Number1
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