MAUDE Adverse Event Report: CARDINAL HEALTH 200, LLC CARDINAL HEALTH; GENERAL SURGERY TRAY

Model Number SBA7CTPY11

Device Problem Component Missing (2306)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/24/2022

Event Type  malfunction  

Event Description

Upon opening for a case and performing a first count, the surgical technician notices a suture boot rack with only 9 suture boots.After extensibility looking at the back table and being unable to locate the suture boot, it was determined that the suture boot must have been missing from the pack because it did not have an indentation in the holder like the rest of the sb did.The pack was removed and replaced without delay.Manufacturer response for suture boot pack, suture boots transplant pack (per site reporter) or manager escalated it immediately to the representative.

Event Description

Upon opening for a case and performing a first count, the surgical technician notices a suture boot rack with only 9 suture boots.After extensibility looking at the back table and being unable to locate the suture boot, it was determined that the suture boot must have been missing from the pack because it did not have an indentation in the holder like the rest of the sb did.The pack was removed and replaced without delay.Manufacturer response for suture boot pack, suture boots transplant pack (per site reporter).Or manager escalated it immediately to the representative.

• Brand Name: CARDINAL HEALTH
• Type of Device: GENERAL SURGERY TRAY
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC; 3651 birchwood drive; waukegan IL 60085
• MDR Report Key: 14873718
• MDR Text Key: 295054702
• Report Number: 14873718
• Device Sequence Number: 1
• Product Code: LRO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 06/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: SBA7CTPY11
• Device Catalogue Number: SBA7CTPY11
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/22/2022
• Event Location: Hospital
• Date Report to Manufacturer: 06/30/2022
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other