MAUDE Adverse Event Report: CARDINAL HEALTH 200 LLC CARDINAL; LAP PACK/ TUBING WITH FILTER INSUFLATION

Catalog Number SBA24LALCH

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/19/2018

Event Type  malfunction  

Event Description

Insufflation tubing in lap pack broken upon pack inspection.

• Brand Name: CARDINAL
• Type of Device: LAP PACK/ TUBING WITH FILTER INSUFLATION
• Manufacturer (Section D): CARDINAL HEALTH 200 LLC
• MDR Report Key: 7628873
• MDR Text Key: 112177455
• Report Number: MW5077996
• Device Sequence Number: 1
• Product Code: NKC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Caregivers
• Type of Report: Initial
• Report Date: 06/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SBA24LALCH
• Device Lot Number: 915302
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/21/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1