MAUDE Adverse Event Report: CARDINAL MINOR PACK

Catalog Number SUT24ORGMS

Device Problem Packaging Problem (3007)

Patient Problem No Patient Involvement (2645)

Event Date 05/12/2017

Event Type  malfunction  

Event Description

During opening count, it was found that there was 21 raytec sponges in the minor pack.After two more counts to verify extra sponge, one was removed before the patient entered the room to maintain sponge counts in multiples of 10."cardinal minor procedure pack" ref "(b)(4)" lot 659231.

• Brand Name: MINOR PACK
• Type of Device: MINOR PACK
• Manufacturer (Section D): CARDINAL
• MDR Report Key: 6568717
• MDR Text Key: 75327719
• Report Number: MW5069800
• Device Sequence Number: 1
• Product Code: EFQ
• 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: 05/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SUT24ORGMS
• Device Lot Number: 659231
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1