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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VARISOFT; COMFORT SHORT 60/13 TCAP
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VARISOFT; COMFORT SHORT 60/13 TCAP Back to Search Results
Lot Number 5191625
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 the tubing separated (not disconnected but broke off) at the site on his infusion set.He did not notice any damage when the package was first opened.No further information available.
 
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Brand Name
VARISOFT
Common Device Name
COMFORT SHORT 60/13 TCAP
MDR Report Key8494757
Report Number8021545-2019-00123
Device Sequence Number13688479
Product Code FPA
UDI-Device Identifier05705244014695
UDI-Public05705244014695
Combination Product (Y/N)N
PMA/510(K) Number
K162812
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 Number5191625
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 03/07/2018
Initial Report FDA Received Date04/09/2019
Patient Sequence Number1
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