MAUDE Adverse Event Report: CARDINAL HEALTH STERILE CATH TRAY; CARDIAC CATHETERIZATION KIT

Lot Number 450861

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 11/08/2017

Event Type  Injury  

Event Description

Note from pi: contacted to obtain more information as follows: device is a transfer decanter that comes pre-stocked in the cath tray by the manufacturer (cardinal health).This has occurred multiple times in the past few weeks from same lot number (450861).

• Brand Name: STERILE CATH TRAY
• Type of Device: CARDIAC CATHETERIZATION KIT
• Manufacturer (Section D): CARDINAL HEALTH; 785 fort mill hwy.; fort mill SC 29707
• MDR Report Key: 7145482
• MDR Text Key: 95738630
• Report Number: 7145482
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2017
• Is this an Adverse Event Report?: Yes
• Device Operator: Other
• Device Expiration Date: 05/01/2020
• Device Lot Number: 450861
• Other Device ID Number: MANUFACTURER DATE 8/14/2017
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/20/2017
• Event Location: Hospital
• Date Report to Manufacturer: 11/20/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1