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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WILLIAM COOK AUSTRALIA DOUBLE LUMEN OVUM ASPIRATION NEEDLE; NONE
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WILLIAM COOK AUSTRALIA DOUBLE LUMEN OVUM ASPIRATION NEEDLE; NONE Back to Search Results
Catalog Number K-0PSD-1633-A-S-US
Device Problem Structural Problem (2506)
Patient Problem Hemorrhage/Bleeding (1888)
Event Type  Injury  
Event Description
It was reported that excessive bleeding occurred in multiple cases (exact number still to be determined) with the use of needles from this particular batch, allegedly due to the needles being too sharp.No specific event date or information was provided for each case.The pt was either cauterized, sutured, or extended pressure was applied to stop the bleeding.
 
Manufacturer Narrative
Udi#: (b)(4).Investigation still in progress.
 
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Brand Name
DOUBLE LUMEN OVUM ASPIRATION NEEDLE
Type of Device
NONE
Manufacturer (Section D)
WILLIAM COOK AUSTRALIA
brisbane
AS 
Manufacturer Contact
berneen gardiner, mgr
brisbane technology park
95 brandl str
eight mile plains, qld AU 41-13
AS   AU 4113
38411188
MDR Report Key4235949
MDR Text Key4996665
Report Number9680654-2014-00025
Device Sequence Number1
Product Code MQE
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K983593
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Distributor
Reporter Occupation Other
Type of Report Initial
Report Date 10/28/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/30/2014
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date02/12/2017
Device Catalogue NumberK-0PSD-1633-A-S-US
Device Lot NumberA932535
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer10/07/2014
Is the Reporter a Health Professional? Yes
Date Manufacturer Received09/30/2014
Was Device Evaluated by Manufacturer? No
Date Device Manufactured02/01/2014
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 Outcome(s) Required Intervention;
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