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

Model Number SAN23HVRHA

Device Problem Material Disintegration (1177)

Patient Problems Low Blood Pressure/ Hypotension (1914); Loss of consciousness (2418); Foreign Body In Patient (2687)

Event Date 07/06/2018

Event Type  Injury  

Manufacturer Narrative

Sample is in route to the manufacturer for evaluation.A follow-up report will be made when evaluation is finalized.

Event 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.

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
• Type of Device: GENERAL SURGERY TRAY (KIT)
• Manufacturer (Section D): SC003 SC-FORT MILL; 785 fort mill hwy.; fort mill SC 29707
• MDR Report Key: 7748129
• MDR Text Key: 115969094
• Report Number: 1423537-2018-00230
• Device Sequence Number: 1
• Product Code: LRO
• UDI-Device Identifier: 10887488400150
• UDI-Public: 10887488400150
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 12/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SAN23HVRHA
• Device Catalogue Number: SAN23HVRHA
• Device Lot Number: NONE
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/06/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 75 YR
• Patient Weight: 77