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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MALLINCKRODT CANADA 30327 MONOJECT 3CC SALINE PREFILLED; PRE-FILL SALINE SYRINGE
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MALLINCKRODT CANADA 30327 MONOJECT 3CC SALINE PREFILLED; PRE-FILL SALINE SYRINGE Back to Search Results
Model Number 8881570300
Device Problems Incomplete or Missing Packaging (2312); Tear, Rip or Hole in Device Packaging (2385); Mechanics Altered (2984)
Patient Problem No Patient Involvement (2645)
Event Date 01/19/2014
Event Type  malfunction  
Event Description
It was reported to covidien on (b)(6) 2014 that a customer had an issue with a pre-fill syringe.The customer reports the saline flush syringe was received empty; contained no solution and also flanges appear deformed and cracks present in syringe barrel adjacent to flange.
 
Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
 
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Brand Name
30327 MONOJECT 3CC SALINE PREFILLED
Type of Device
PRE-FILL SALINE SYRINGE
Manufacturer (Section D)
MALLINCKRODT CANADA
7500 trans canda hwy
point claire, qc H9R 5H8
CA  H9R 5H8
Manufacturer (Section G)
MALLINCKRODT CANADA
7500 trans canda hwy
pointe claire, qc H9R
CA   H9R
Manufacturer Contact
elaine bishop
15 hampshire street
mansfield, MA 02048
5084524686
MDR Report Key3745609
MDR Text Key4221476
Report Number1282497-2014-00018
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 Health Professional,User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 02/04/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/04/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number8881570300
Device Catalogue Number8881570300
Device Lot Number13I2114
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer02/11/2014
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/04/2014
Is the Device Single Use? Yes
Type of Device Usage Unknown
Patient Sequence Number1
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