MAUDE Adverse Event Report: 3M COMPANY STERI-DRAPE¿; DRAPE, STERILE SURGICAL, X-RAY IMAGE INTENSIFIER DRAPE

Catalog Number	1013
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/06/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Sterile barrier issue with c-arm drapes x 2 w/ same lot number.The first drape seemed to be melted & stuck together; 2nd drape was split open, not intact.

• Brand Name: STERI-DRAPE¿
• Common Device Name: DRAPE, STERILE SURGICAL, X-RAY IMAGE INTENSIFIER DRAPE
• Manufacturer (Section D): 3M COMPANY; 3m center, 2510 conway ave.; bldg. 275-5w-06; saint paul MN 55144
• MDR Report Key: 8443241
• Report Number: 8443241
• Device Sequence Number: 11209026
• Product Code: PUI
• UDI-Device Identifier: 00707387020910
• UDI-Public: (01)00707387020910(17)231213(10)202312XD
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/08/2019
• Report Date (Section F): 03/08/2019

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: No Information
• Device Catalogue Number: 1013
• Device Lot Number: 202312XD
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 03/22/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 03/08/2019