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

Model Number 8881590125

Device Problems Nonstandard Device (1420); Device Operates Differently Than Expected (2913)

Patient Problem Bacterial Infection (1735)

Event Date 08/12/2013

Event Type  Other  

Event Description

It was reported to covidien on (b)(4) 2014 that a customer had an issue with a pre-filled syringe.Per maude event report, the customer reports the pt is pre-transplant status for myelofibrosis.The pt received affected medication.Blood cultures were performed due to risk from the heparin recall.The cultures were positive for micrococcus from one of the hickman lumens.The pt was treated as an outpatient on iv vancomycin q12h x 7 days for line infection.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).

• Brand Name: 30327 12CC 100 UNIT HEP SYR {CAN} (5CC)
• Type of Device: HEPARIN PRE-FILL
• 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 H9R 5H8; CA H9R 5H8
• Manufacturer Contact: elaine bishop ; 15 hampshire st.; mansfield, MA 02048 ; 5084524686
• MDR Report Key: 3622182
• MDR Text Key: 15323517
• Report Number: 1282497-2014-00009
• Device Sequence Number: 1
• Product Code: NZW
• Combination Product (y/n): N
• Number of Events Reported: 1
• 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

• Date FDA Received: 02/03/2014
• 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: 01/30/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other