COOK SPECTRUM * C-HASY-301J

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-08-27 for COOK SPECTRUM * C-HASY-301J manufactured by Cook Medical.

Event Text Entries

[1263766] Staff noted that there is no filter needle included in this kit, although the medication included in the kit is in an ampule. All lots from this product are affected--this is not a case of a filter needle missing from one kit: it is not included in the kit at all. All clinical references indicate that a medication drawn from an ampule should be drawn up with a filter needle. When interviewing nursing staff and physicians who use this kit routinely, all indicated that "everything needed is in the kit. " it is not their practice to pull a sterile filter needle or use one when using the kit, although all said that if they were drawing up from an ampule, a filter needle should be used. Members of the healthcare team recommend the manufacturer consider one of the following:1. Change the medication in the kit from an ampule to a multi-dose vial. 2. Include a filter needle in the kit as a standard piece of equipment if a multi-dose vial is not an option. 3. Reference current literature and/or research findings regarding drawing up medications from an ampule without a filter needle. This device is used in nicu and picu. The kit contains an ampule of lidocaine solution. Manufacturer response (as per reporter) for silicone central venous catheter tray, cook spectruma copy of this report has been faxed to the manufacturer.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1466652
• MDR Report Key: 1466652
• Date Received: 2009-08-27
• Date of Report: 2009-08-27
• Date of Event: 2009-08-27
• Report Date: 2009-08-27
• Date Reported to FDA: 2009-08-27
• Date Added to Maude: 2009-09-10
• Event Key: 0
• Report Source Code: User Facility 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: RISK MANAGER
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 0
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: COOK SPECTRUM
• Generic Name: KIT, CENTRAL CATHETER, NEEDLE
• Product Code: OFF
• Date Received: 2009-08-27
• Model Number: *
• Catalog Number: C-HASY-301J
• Lot Number: *
• ID Number: *
• Operator: PHYSICIAN
• Device Availability: Y
• Device Age: 1 DY
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: COOK MEDICAL
• Manufacturer Address: PO BOX 4195 BLOOMINGTON IN 47402419 US 47402 4195

Patients

Patient Number	Treatment	Outcome	Date
1	0		2009-08-27