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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTEGRA NEUROSCIENCES PR ACCUDRAIN WITHOUT THE ANTI-REFLUX VALVE
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INTEGRA NEUROSCIENCES PR ACCUDRAIN WITHOUT THE ANTI-REFLUX VALVE Back to Search Results
Catalog Number INS8400
Device Problems Break (1069); Detachment Of Device Component (1104); Component Falling (1105)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/22/2014
Event Type  malfunction  
Event Description
The accudrain was first connected to the pt on (b)(6) and manipulated regularly on a daily basis.On the night of (b)(6) 2014 while the rn was adjusting the level of the burette, the left side of the pinch lock broke off.However, the nurse observed that the burette was still able to remain in position.Shortly thereafter, the nurse attempted to change the collection bag and the luer lock twist cap completely fell off the bottom of the drain.At this point, they had to replace the drain.There was no pt injury.
 
Manufacturer Narrative
To date, the device involved in the reported incident has not been received for evaluation.An investigation hs been initiated based upon the reported info.
 
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Brand Name
ACCUDRAIN WITHOUT THE ANTI-REFLUX VALVE
Type of Device
NA
Manufacturer (Section D)
INTEGRA NEUROSCIENCES PR
anasco PR 00610
Manufacturer Contact
rowena bunuan
315 enterprise drive
plainsboro, NJ 08536
6099362393
MDR Report Key4317145
MDR Text Key15114378
Report Number2648988-2014-00062
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K042825
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 10/23/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/18/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberINS8400
Device Lot Number1141446
Was Device Available for Evaluation? Yes
Date Manufacturer Received10/23/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age55 YR
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