MAUDE Adverse Event Report: CARDINAL HEALTH D.R. 203 II LTD SHOULDER DRAPE PACK, TIBURON; GENERAL SURGERY TRAY (KIT)

Catalog Number	29367
Health Effect - Clinical Code	Skin Tears (2516)
Date of Event	02/13/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The sample and the lot# were not provided.Since the lot number was not available, the device history record could not be reviewed.A verification of the last 12 months of inspection data confirms that no issues of this nature were detected.An investigation was conducted and we were able to confirm that the process is in compliance with applicable standard production method (spm).We verified that all devices are made with qualified, tested and approved materials.We also, verified that the operators are certified in their operations.The product is randomly inspected according to the approved sampling plan, and several quality checks are conducted during the manufacturing process.The drape is produced with qualified and approve materials.Since the lot number was not provided, we were unable to confirm the traceability for the adhesive.However, a reviewed of the records for the last 12 months was verified, and based on the incoming testing results, no deviations took place with the raw materials used in the manufacturing process.Without the sample, a root cause could not be determined.We will continue to monitor complaints for any trends.
Event or Problem Description
Patient experienced a skin tear during removal of drape.Steri-strips were applied.Per md, patient is well.

• Brand Name: SHOULDER DRAPE PACK, TIBURON
• Common Device Name: GENERAL SURGERY TRAY (KIT)
• Manufacturer (Section D): CARDINAL HEALTH D.R. 203 II LTD; zona franca las americas km22,; santo domingo ; DR
• MDR Report Key: 7341891
• Report Number: 1423537-2018-00168
• Device Sequence Number: 555054
• Product Code: LRO
• UDI-Device Identifier: 10885380141119
• UDI-Public: 10885380141119
• 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
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 03/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 29367
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/15/2018
• Initial Report FDA Received Date: 03/15/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 19 YR
• Patient Weight: 56