MAUDE Adverse Event Report: MALLINCKRODT 30327 12CC SLNE. SYR. [CAN] [5CC]; SALINE SYRINGE

Model Number 8881570125

Device Problem Insufficient Information (3190)

Patient Problems Headache (1880); Tinnitus (2103); Chills (2191); Dizziness (2194); Malaise (2359); No Code Available (3191)

Event Date 07/01/2013

Event Type  Other  

Event Description

It was reported to covidien on (b)(6) 2013 that a customer had an issue with a saline syringe.The customer reports having severe chills and malaise after treatments.The customer reports a headache, buzzing in the ears, loss of appetite, and dizziness.The customer reports receiving humate p at home 2 times weekly.

Manufacturer Narrative

An investigation is currently underway; upon completion, the results will be forwarded.(b)(4).

• Brand Name: 30327 12CC SLNE. SYR. [CAN] [5CC]
• Type of Device: SALINE SYRINGE
• Manufacturer (Section D): MALLINCKRODT; 7500 trans canada hwy; quebec H9R 5H8; CA H9R 5H8
• Manufacturer (Section G): MILLINCKRODT; 7500 trans canada hwy; quebec H9R ; CA H9R
• Manufacturer Contact: elaine bishop ; 15 hampshire st.; mansfield, MA 02048 ; 5084524686
• MDR Report Key: 3581687
• MDR Text Key: 4032653
• Report Number: 1282497-2014-00002
• 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: Other
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 12/30/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Expiration Date: 11/01/2014
• Device Model Number: 8881570125
• Device Catalogue Number: 8881570125
• Device Lot Number: 12L3084
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/30/2013
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other