CT TRI-PAK

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-01-15 for CT TRI-PAK manufactured by Medrad.

Event Text Entries

[16703126] Medrad ct tri-pak -sterile disposable syringe lot 84239 use by 08/2013 date of manufacture 2008/08 bracco diagnostics isovue-250 100ml vial lot 7k39751, exp nov 2010. When filling medrad syringe with isovue, tech noted clear plastic floating in syringe - it is not clear whether the plastic fits from the syringe or the medication but due to the size of the object, it more likely was present in the syringe prior to drawing up of the medication. Device nor medication was used on a pt. Device will be held by director of pharmacy at for a minimum of six months. Diagnosis or reason for use: ct scan with contrast - device not used. Dose: 100 ml.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

Report Number	MW5009645
MDR Report Key	1293730
Date Received	2009-01-15
Date of Report	2009-01-15
Date of Event	2009-01-08
Date Added to Maude	2009-01-30
Event Key	0
Report Source Code	Voluntary report
Manufacturer Link	N
Number of Patients in Event	0
Adverse Event Flag	3
Product Problem Flag	3
Reprocessed and Reused Flag	0
Reporter Occupation	PHARMACIST
Health Professional	3
Initial Report to FDA	3
Report to FDA	0
Event Location	0
Single Use	0
Previous Use Code	0
Event Type	3
Type of Report	3

Device Sequence Number: 1

Brand Name	CT TRI-PAK
Generic Name	NONE
Product Code	DXT
Date Received	2009-01-15
Lot Number	84239
ID Number	0270131702
Device Expiration Date	2013-08-31
Device Availability	Y
Device Sequence No	1
Device Event Key	0
Manufacturer	MEDRAD

Device Sequence Number: 2

Brand Name	ISOVUE-250-100ML
Generic Name	NONE
Product Code	KTA
Date Received	2009-01-15
Lot Number	7K39751
Device Expiration Date	2010-11-30
Device Availability	Y
Device Sequence No	2
Device Event Key	0
Manufacturer	BRACCO

Patients

Patient Number	Treatment	Outcome	Date
1	0		2009-01-15