CARDINAL * 4301C

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-08-31 for CARDINAL * 4301C manufactured by Cardinal Health.

Event Text Entries

[21396812] 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. Manufacturer response (as per reporter) for lumbar puncture tray, cardinala copy of this report has been faxed to the manufacturer.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1472631
• MDR Report Key: 1472631
• Date Received: 2009-08-31
• Date of Report: 2009-08-31
• Date of Event: 2009-08-31
• Report Date: 2009-08-31
• Date Reported to FDA: 2009-08-31
• Date Added to Maude: 2009-09-15
• 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: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: CARDINAL
• Generic Name: LUMBAR PUNCTURE TRAY
• Product Code: OGJ
• Date Received: 2009-08-31
• Model Number: *
• Catalog Number: 4301C
• Lot Number: *
• ID Number: *
• Operator: PHYSICIAN
• Device Availability: Y
• Device Age: 1 DY
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: CARDINAL HEALTH
• Manufacturer Address: 10020 PACIFIC MESA BLVD. SAN DIEGO CA 92121 US 92121

Patients

Patient Number	Treatment	Outcome	Date
1	0		2009-08-31