MAUDE Adverse Event Report: CARDINAL HEALTH 200, LLC PRESOURCE CUSTOM STERILE SURGICAL AND PROCEDURE KITS; GENERAL SURGERY TRAY (KIT)

Catalog Number SCV56HOPAA

Device Problem Device Contaminated During Manufacture or Shipping (2969)

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

Event Date 01/04/2017

Event Type  malfunction  

Event Description

In opening up the sterile pack cv open heart scv56hopaa a black hair was noted to be embedded in the sterile sponges.Manufacturer response for sterile surgical pack specialized cardiac or, presource pack cv open heart pch (per site reporter): i haven't heard back from the local rep for cardinal health email sent 1/12.

• Brand Name: PRESOURCE CUSTOM STERILE SURGICAL AND PROCEDURE KITS
• Type of Device: GENERAL SURGERY TRAY (KIT)
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC; 785 fort mill hwy.; fort mill SC 29707
• MDR Report Key: 6275651
• MDR Text Key: 65687848
• Report Number: 6275651
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 03/01/2021
• Device Catalogue Number: SCV56HOPAA
• Device Lot Number: 587019
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/12/2017
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 01/12/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1