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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION UT/USA EPIDURAL TRAY, 18G; 44 - TRAYS

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INTEGRA LIFESCIENCES CORPORATION UT/USA EPIDURAL TRAY, 18G; 44 - TRAYS Back to Search Results
Catalog Number 20-1462-01
Device Problem Tear, Rip or Hole in Device Packaging (2385)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
To date the device involved in the reported incident has not been received for evaluation.An investigation has been initiated based on the reported information.
 
Event Description
Torn wrap.
 
Manufacturer Narrative
10/5/2015 integra investigation completed.Method: failure analysis, device history evaluation.Results: failure analysis - the product has not been returned for review, a failure analysis is not possible.Device history evaluation - the device history record indicates the product was made according to specifications at the time of manufacture.Conclusion: the device history record indicates the product was made according to specifications at the time of manufacture.
 
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Brand Name
EPIDURAL TRAY, 18G
Type of Device
44 - TRAYS
Manufacturer (Section D)
INTEGRA LIFESCIENCES CORPORATION UT/USA
3395 west 1820 south
3395 west 1820 south
salt lake city UT 84104
Manufacturer (Section G)
INTEGRA LIFESCIENCES CORPORATION UT/USA
3395 west 1820 south
salt lake city UT 84104
Manufacturer Contact
sandra lee
311 enterprise drive
311 enterprise drive
plainsboro, NJ 08536
6099362393
MDR Report Key5067461
MDR Text Key25383388
Report Number1722447-2015-00010
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
PMA/PMN Number
K935245
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation Nurse
Report Date 08/20/2015
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 Catalogue Number20-1462-01
Device Lot NumberW1504095
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received09/10/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/01/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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