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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MALLINCKRODT CANADA 30327 12CC SALINE SYRINGE {CAN}(10CC)
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MALLINCKRODT CANADA 30327 12CC SALINE SYRINGE {CAN}(10CC) Back to Search Results
Model Number 8881570121
Device Problem Component Missing (2306)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/27/2014
Event Type  Other  
Event Description
It was reported to covidien on (b)(6) 2014 that a customer had an issue with a pre-fill syringe.The customer states that the customer used the saline flush out of the secondary packed medline tray.The nurse noticed that the syringe was pulled back like a normal syringe, however it was not filled with saline, just air.
 
Manufacturer Narrative
An investigation is currently underway.Upon completion the results will be forwarded.
 
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Brand Name
30327 12CC SALINE SYRINGE {CAN}(10CC)
Type of Device
SALINE SYRINGE
Manufacturer (Section D)
MALLINCKRODT CANADA
750 trans canada hwy
pointe claire quebec H9R 5H8
CA  H9R 5H8
Manufacturer (Section G)
MALLINCKRODT CANADA
750 trans canada hwy
pointe claire, quebec H9R 5H8
CA   H9R 5H8
Manufacturer Contact
elaine bishop
15 hampshire st.
mansfield, MA 02048
5084524686
MDR Report Key3767719
MDR Text Key4468672
Report Number1282497-2014-00028
Device Sequence Number1
Product Code NGT
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility,Company Representative
Reporter Occupation Not Applicable
Type of Report Initial
Report Date 03/31/2014
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 Model Number8881570121
Device Catalogue Number8881570121
Device Lot Number13H1994
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer04/09/2014
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 03/31/2014
Initial Date FDA Received04/16/2014
Is the Device Single Use? Yes
Type of Device Usage Unknown
Patient Sequence Number1
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