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

Model Number 8881590125

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Death (1802)

Event Type  Death  

Manufacturer Narrative

Submit date: 09/14/2015.An investigation is currently under way; upon completion the results will be forwarded.

Event Description

It was reported to covidien on 08/20/2015 that a customer had an issue with a pre-fill syringe.On (b)(6) 2015 covidien was informed of a customer who had an issue with a prefilled syringe.The attorney alleges that on sunday, (b)(6) 2013, the patient received heparin 100 units/ml-5 ml, as prescribed, through a disposable syringe, as part of a regimen of her home health care.Almost immediately after receiving the dose of heparin, the patient began experiencing the onset of adverse physical symptoms.On monday, (b)(6) 2013, the patient was admitted to the hospital where her symptoms continued to worsen, without any apparent medical explanation, the patient died on (b)(6) 2013.

Manufacturer Narrative

There were no samples received with this complaint and therefore an examination of the reported issue could not be made to determine the root cause.A device history record (dhr) review was completed for lot number 13d0824n which was manufactured in may of 2013.There were no manufacturing issues related to the complaint issued for this lot.All results for the lot were within the required parameters.This complaint reported could not be confirmed and no root cause could be identified.Because a root cause could not be determined, no corrective or preventive actions will be taken at this time.If additional information or samples are received, the investigation will resume as needed.This complaint will be used for trending purposes.

• Brand Name: 30327 12CC 100 UNIT HEP SYR {CAN} (5CC)
• Type of Device: HEPARIN PRE-FILL
• Manufacturer (Section D): PHARMA CANADA; 7500 trans canada hwy; pointe claire; quebec H9R 1 C7; CA H9R 1C7
• Manufacturer (Section G): PHARMA CANADA; 7500 trans canada hwy.; pointe claire; pointe claire H9R 1 C7; CA H9R 1C7
• Manufacturer Contact: thom mcnamara ; 15 hampshire st; mansfield, MA 02048 ; 5084524811
• MDR Report Key: 5075727
• MDR Text Key: 25731603
• Report Number: 1282497-2015-00045
• Device Sequence Number: 1
• Product Code: NZW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: 8881590125
• Device Catalogue Number: 8881590125
• Device Lot Number: 13D0824N
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/27/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Death