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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTEGRA INTEGRA ACCUDRAIN WITH ANTI-REFLUX VALVE STAND, INFUSION

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INTEGRA INTEGRA ACCUDRAIN WITH ANTI-REFLUX VALVE STAND, INFUSION Back to Search Results
Catalog Number INS8401
Device Problems Break (1069); Crack (1135)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/03/2017
Event Type  malfunction  
Event Description
The device had a crack to the proximal port and was broken at the stopcock.
 
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Brand NameINTEGRA ACCUDRAIN WITH ANTI-REFLUX VALVE
Type of DeviceSTAND, INFUSION
Manufacturer (Section D)
INTEGRA
plainsboro NJ 08536
MDR Report Key7302545
MDR Text Key101346086
Report NumberMW5075575
Device Sequence Number1
Product Code FOX
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 02/26/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/27/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberINS8401
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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