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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MALLINCKRODT CANADA 30327 12CC 100 UNIT HEP SYR {CAN} (5CC); HEPARIN PRE-FILL SYRINGE

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MALLINCKRODT CANADA 30327 12CC 100 UNIT HEP SYR {CAN} (5CC); HEPARIN PRE-FILL SYRINGE Back to Search Results
Model Number 8881590125
Device Problems Nonstandard Device (1420); Device Operates Differently Than Expected (2913)
Patient Problem Fever (1858)
Event Date 07/30/2013
Event Type  Other  
Event Description
It was reported to covidien on (b)(4) 2014 that a customer had an issue with a pre-fill syringe.Per (b)(4) report, the customer reports the pt received affected medication.The pt had stem cell transplant.Later the same day, the pt presented with neutropenic fever to the cancer clinic, which prompted the pt to be admitted to the hospital.The pt was in the hospital with neutropenic fever.Blood cultures were negative for bacterial growth, however, the pt was treated with iv abx during the whole time in the hospital.The pt was admitted for neutropenic fever associated with the transplant process.Dose: 5ml iv qd per lumen.Diagnosis for use: central line maintenance.
 
Manufacturer Narrative
An investigation is currently underway, upon completion the results will be forwarded.(b)(4).
 
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Brand Name
30327 12CC 100 UNIT HEP SYR {CAN} (5CC)
Type of Device
HEPARIN PRE-FILL SYRINGE
Manufacturer (Section D)
MALLINCKRODT CANADA
7500 trans canada hwy.
pointe claire, qc H9R 5H8
CA  H9R 5H8
Manufacturer (Section G)
MALLINCKRODT CANADA
7500 trans canada hwy.
pointe claire, qc
CA  
Manufacturer Contact
elaine bishop
15 hampshire st.
mansfield, MA 02048
5084524686
MDR Report Key3622183
MDR Text Key16912111
Report Number1282497-2014-00010
Device Sequence Number1
Product Code NZW
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other
Reporter Occupation Not Applicable
Remedial Action Recall
Type of Report Initial
Report Date 01/30/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Model Number8881590125
Device Catalogue Number8881590125
Device Lot Number13D0824N
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 01/30/2014
Initial Date FDA Received02/03/2014
Is the Device Single Use? Yes
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Other;
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