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

Model Number SMA56DBIHF

Device Problem Component Missing (2306)

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

Event Date 03/02/2020

Event Type  malfunction  

Event 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
• Type of Device: LABOR AND DELIVERY KIT
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC; 785 fort mill hwy.; fort mill SC 29707
• MDR Report Key: 9859763
• MDR Text Key: 184276910
• Report Number: 9859763
• Device Sequence Number: 1
• Product Code: MLS
• UDI-Device Identifier: 10887488814766
• UDI-Public: (01)10887488814766
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: SMA56DBIHF
• Device Catalogue Number: SMA56DBIHF
• Device Lot Number: 352908
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/03/2020
• Device Age: 3 MO
• Event Location: Hospital
• Date Report to Manufacturer: 03/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 9125 DA
• Patient Weight: 67