MAUDE Adverse Event Report: CARDINAL HEALTH FORT MILL SHOULDER ARTHROSCOPY (SASBB)575; GENERAL SURGERY TRAY (KIT)

Model Number	SOP40SASBC
Date of Event	09/21/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
During a shoulder arthroscopy the patient developed a rash from the drape, u, 60 x 72 in, fan folded, w/adhesive,ns requiring cleansing of affected skin and application of bacitracin and gauze 4 x 4.We were unable to conduct a device history record review for the given product quality report, as the lot provided is invalid.However, a verification of the final inspection records for the given product catalog number over the last 6 months, does not show an incidence or trend related to the issue reported.All devices are made with qualified, tested and approved materials.We also verified that the operators are certified in their operations and in compliance with applicable standard production method (spm).The product is randomly inspected according to the approved sampling plan where this condition is verified by the qa inspectors.Since a sample is not available, a root cause for this issue could not be determined.Based on the process evaluation and the investigation conducted, we are unable to determine the root cause for this issue.If a sample is returned at a later date, an addendum to this investigation will be performed.
Event or Problem Description
This account is having issues with pack sop40sasbc lot #449418 and the u-drape 8476.Based on the customer information submitted, the patient developed a rash from the drape after surgery.The patient was treated with bacitracin and a 4x4 to rash area.

• Brand Name: SHOULDER ARTHROSCOPY (SASBB)575
• 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: 6966301
• Report Number: 1423537-2017-00134
• Device Sequence Number: 10904270
• Product Code: LRO
• UDI-Device Identifier: 10887488532561
• UDI-Public: 10887488532561
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/20/2017

1 Device was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: No Information
• Device Model Number: SOP40SASBC
• Device Catalogue Number: SOP40SASBC
• Device Lot Number: 449418
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 10/03/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/03/2017
• Initial Report FDA Received Date: 10/20/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No