MAUDE Adverse Event Report: CARDINAL CUSTOM STERILE CATH LAB PACK

Catalog Number SAN24CC97C

Device Problems Delivered as Unsterile Product (1421); Device Contamination with Chemical or Other Material (2944)

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

Event Date 03/16/2016

Event Type  malfunction  

Event Description

Debris found in the sterile bowl in a custom sterile cath lab pack.A new pack was opened and the debris was isolated.

• Brand Name: CUSTOM STERILE CATH LAB PACK
• Type of Device: CATH LAB PACK
• Manufacturer (Section D): CARDINAL
• MDR Report Key: 5522263
• MDR Text Key: 41142277
• Report Number: MW5061227
• Device Sequence Number: 1
• Product Code: LRO
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/21/2016

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 Expiration Date: 09/01/2018
• Device Catalogue Number: SAN24CC97C
• Device Lot Number: 467471
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 03/18/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/21/2016
• Type of Device Usage: N
• Patient Sequence Number: 1