MAUDE Adverse Event Report: CARDINAL HEALTH FORT MILL EXPLORATORY LAP PACK (ELCCA)119; GENERAL SURGERY TRAY (KIT)

Model Number	SLC40ELCCB
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/05/2016
Type of Reportable Event	Malfunction
Event or Problem Description
Based on the information from the customer the gown a9040na had strike through on the sleeve.The patient had (b)(6).Several attempts were made to gather more information for this report, however the doctor would not provide any additional information.
Additional Manufacturer Narrative
One decontaminated sample received, gown (b)(4).Left sleeve has evidence of blood on the exterior part.Cuff is clean, does not have any blood on it.The interior of the sleeve shows shadowing due to large amount of blood on the exterior.Material is intact.There is no indication of material failure that would pose as a risk of strike through. right sleeve has indication of blood on exterior and blood saturation of the cuff.There is blood on the interior but it is due to the cuff being saturated.Material is intact.No indication of material failure.  a device history record (dhr) review was completed on lot# 0726cw.Product was manufactured on march 15th 2016.No quality issues were reported.The root cause is saturation of the cuff and blood leaking to the interior of the sleeve.There was no indication of failure in the material.No corrective action at this time, however we will continue to monitor the trend of this type of incident.

• Brand Name: EXPLORATORY LAP PACK (ELCCA)119
• Common Device Name: GENERAL SURGERY TRAY (KIT)
• Manufacturer (Section D): CARDINAL HEALTH FORT MILL; 785 fort mill hwy.; fort mill SC 29707
• MDR Report Key: 5952552
• Report Number: 1423537-2016-00044
• Device Sequence Number: 697385
• Product Code: LRO
• UDI-Device Identifier: 10887488236506
• UDI-Public: 10887488236506
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Model Number: SLC40ELCCB
• Device Catalogue Number: SLC40ELCCB
• Device Lot Number: 393395
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 08/22/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 08/22/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/15/2016
• Supplement Report FDA Received Date: 10/20/2016
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other