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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTEGRA NEUROSCIENCES IMPANTS S.A. PERTINOEAL CATHETER; VALVE ACCESSORIES
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INTEGRA NEUROSCIENCES IMPANTS S.A. PERTINOEAL CATHETER; VALVE ACCESSORIES Back to Search Results
Lot Number 182305
Device Problems Hole In Material (1293); Material Integrity Problem (2978); Torn Material (3024)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Event Description
It was reported that the peritoneal catheter was extremely fragile, tore easily, and had numerous holes in it.There was a surgical delay of 10 minutes.No other information provided.Several attempts were made to obtain additional information.To date, no new information has been provided by the customer.
 
Manufacturer Narrative
To date, the device involved in the reported incident has not been received for evaluation.An investigation has been initiated based upon the reported information.
 
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Brand Name
PERTINOEAL CATHETER
Type of Device
VALVE ACCESSORIES
Manufacturer (Section D)
INTEGRA NEUROSCIENCES IMPANTS S.A.
sophia antipolis F-069 21
Manufacturer Contact
rowena bunaun
315 enterpise drive
plainsboro, NJ 08536
6099362393
MDR Report Key3894506
MDR Text Key4676939
Report Number9612007-2014-00015
Device Sequence Number1
Product Code MSD
Combination Product (y/n)N
Reporter Country CodeUS
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 04/03/2014
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
Device Operator Health Professional
Device Lot Number182305
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 04/03/2014
Initial Date FDA Received04/25/2014
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 Unknown
Patient Sequence Number1
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