MAUDE Adverse Event Report: SC003 SC-FORT MILL HEART AND VASCULAR UNIV PACK 164; GENERAL SURGERY TRAY (KIT)

Model Number	SAN23HVRHA
Health Effect - Clinical Codes	Low Blood Pressure/ Hypotension (1914); Loss of consciousness (2418); Foreign Body In Patient (2687)
Date of Event	07/06/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Sample is in route to the manufacturer for evaluation.A follow-up report will be made when evaluation is finalized.
Event or Problem Description
The blue towels pwtb03-stma was linting within pack san23hvrha.The lint was found on the towels, sterile gloves of the surgeon and on an interventional wire during a cardiac carotid iabp insertion.The towels are used to dry hands and absorb liquid (water, blood) on the procedure table and scrub table.The patient became unresponsive during the procedure, blood pressure decreased and patient was intubated so the customer felt the linting could have contributed to this.
Additional Manufacturer Narrative
Supplemental report is being filed due to the sample received from the customer to the manufacturer was determined not to be a cardinal health product.Cardinal health's post market surveillance team made several attempts to contact the customer involved in this report in an effort to identify the correct manufacturer of the towel, but no return response was received.No further action is required at this time.

• Brand Name: HEART AND VASCULAR UNIV PACK 164
• Common Device Name: GENERAL SURGERY TRAY (KIT)
• Manufacturer (Section D): SC003 SC-FORT MILL; 785 fort mill hwy.; fort mill SC 29707
• MDR Report Key: 7748129
• Report Number: 1423537-2018-00230
• Device Sequence Number: 1319017
• Product Code: LRO
• UDI-Device Identifier: 10887488400150
• UDI-Public: 10887488400150
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/07/2018

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?: No
• Operator of Device: Health Professional
• Device Model Number: SAN23HVRHA
• Device Catalogue Number: SAN23HVRHA
• Device Lot Number: NONE
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/06/2018
• Supplement Date Received by Manufacturer: 07/06/2018
• Initial Report FDA Received Date: 08/03/2018
• Supplement Report FDA Received Date: 12/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 75 YR
• Patient Weight: 77