MAUDE Adverse Event Report: CARDINAL HEALTH CARDINAL PRESOURCE; STERILE MAJOR BASIN PACK

Model Number SUT21MBARD

Device Problems Hole In Material (1293); Sticking (1597)

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

Event Date 06/06/2017

Event Type  malfunction  

Event Description

During setup of an operating room (or) procedure, the nurse/scrub tech opened a major basin set-up pack.The back table cover was removed to drape on the table.The drape was stuck to itself and would not unfold properly.Additionally there was a hole in the drape, possibly from trying to open the drape.Another pack was used without incident.No patient injury.

• Brand Name: CARDINAL PRESOURCE
• Type of Device: STERILE MAJOR BASIN PACK
• Manufacturer (Section D): CARDINAL HEALTH; 1500 waukegan rd.; waukegan IL 60085
• MDR Report Key: 6650448
• MDR Text Key: 78360913
• Report Number: 6650448
• Device Sequence Number: 1
• Product Code: FNY
• 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: 06/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 11/01/2021
• Device Model Number: SUT21MBARD
• Device Catalogue Number: SUT21MBARD
• Device Lot Number: 691768
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/15/2017
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 06/15/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1