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

Catalog Number SNU21BRDCF

Device Problems Product Quality Problem (1506); Device Contamination with Chemical or Other Material (2944)

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

Event Date 07/10/2019

Event Type  malfunction  

Event Description

We opened a breast reduction pack today that had a hair on one of the packs of laps.Also, the blue towels were smaller than they usually are.

• Brand Name: BREAST REDUCTION PACK
• Type of Device: GENERAL SURGERY TRAY
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC
• MDR Report Key: 8817942
• MDR Text Key: 152091094
• Report Number: MW5088299
• Device Sequence Number: 1
• Product Code: LRO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 07/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/21/2023
• Device Catalogue Number: SNU21BRDCF
• Device Lot Number: 254835
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2019
• 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