MAUDE Adverse Event Report: MALLINCKRODT CANADA 30327 12CC SALINE SYRINGE {CAN} (10CC); PRE-FILL SYRINGE

Model Number 8881570121

Device Problem Nonstandard Device (1420)

Patient Problem Bacterial Infection (1735)

Event Type  Injury  

Event Description

It was reported to covidien on (b)(6) 2015 that a customer had an issue with a pre-fill syringe.The customer reports that his wife has been hospitalized with a high level of unidentified bacteria.The customer stated she was admitted into the hospital and was briefly in icu.The customer reported the product used was the same product from the 2013 recall.

Manufacturer Narrative

An investigation is currently under way; upon completion the results will be forwarded.

Manufacturer Narrative

This report was initially filed as a 5-day but per additional instruction from fda, this file is being corrected as a 30-day report.

Manufacturer Narrative

There were no samples received with this complaint therefore an examination of the reported issue could not be conducted.A review of the device history record was not performed during this investigation as the lot number was not received with the complaint.All device history records are reviewed and approved by quality prior to release of product.Because there was no lot number, a date of manufacture could not be determined.Based on the information available and non-confirmation of the complaint reported, no root cause could be determined and 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 tracking and trending purposes.

• Brand Name: 30327 12CC SALINE SYRINGE {CAN} (10CC)
• Type of Device: PRE-FILL SYRINGE
• Manufacturer (Section D): MALLINCKRODT CANADA; 7500 trans canada hwy.; pointe claire; quebec ; CA
• Manufacturer (Section G): MALLINCKRODT CANADA; 7500 trans canada hwy.; pointe claire; quebec H9R 5 H8; CA H9R 5H8
• Manufacturer Contact: thom mcnamara ; 15 hampshire st; mansfield, MA 02048 ; 5084524811
• MDR Report Key: 4882936
• MDR Text Key: 6264369
• Report Number: 1282497-2015-00030
• Device Sequence Number: 1
• Product Code: NGT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,consumer
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 06/29/2015

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 Number: 8881570121
• Device Catalogue Number: 8881570121
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/29/2015
• Initial Date FDA Received: 07/01/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 07/10/2015; 01/19/2016
• 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): Other