MAUDE Adverse Event Report: CARDINAL HEALTH MEDI VAC; STERILE SUCTION TUBING

Model Number	N510
Health Effect - Clinical Code	No Information (3190)
Date of Event	12/18/2017
Type of Reportable Event	Malfunction
Event or Problem Description
Sterile suction tubing was opened and found to be contaminated.A search of that lot number (j17070434s) found 3 other tubing that also appeared to be contaminated.No contaminated tubing made it to a sterile field (other lots pulled for contamination j16081634s and j16092334s).

• Brand Name: MEDI VAC
• Common Device Name: STERILE SUCTION TUBING
• Manufacturer (Section D): CARDINAL HEALTH; waukegan IL 60085
• MDR Report Key: 7147653
• Report Number: MW5074244
• Device Sequence Number: 904878
• Product Code: JOL
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/22/2017
• 5 Devices were Involved in the Event: 1 2 3 4 5

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: N510
• Device Lot Number: J16092334S
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/26/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1