MAUDE Adverse Event Report: CARDINAL HEALTH 200, LLC CARDINAL HEALTH; LABOR AND DELIVERY KIT

Model Number	SMA56DBIHF
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/02/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Anesthesia monitoring tech opened the "pack ob vag del basin ihc" pack for an ob vaginal delivery and it was missing the pack of sponges.Normally there are 5 sponges packaged in the pack.The tech obtained an additional pack of sponges to add to the delivery table to use with the patient.

• Brand Name: CARDINAL HEALTH
• Common Device Name: LABOR AND DELIVERY KIT
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC; 785 fort mill hwy.; fort mill SC 29707
• MDR Report Key: 9859763
• Report Number: 9859763
• Device Sequence Number: 3836542
• Product Code: MLS
• UDI-Device Identifier: 10887488814766
• UDI-Public: (01)10887488814766
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/03/2020
• Report Date (Section F): 03/03/2020

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
• Operator of Device: No Information
• Device Model Number: SMA56DBIHF
• Device Catalogue Number: SMA56DBIHF
• Device Lot Number: 352908
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Device Age: 3 MO
• Event Location: Hospital
• Date Report to Manufacturer: 03/20/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 67
• Date Report Sent to FDA: 03/03/2020