MAUDE Adverse Event Report: 3M COMPANY STERI-DRAPE¿ IOBAN¿ 2; DRAPE, SURGICAL

Model Number	6619
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/27/2018
Type of Reportable Event	Malfunction
Event or Problem Description
The patient had a total hip and we had steri drapes (ioban) of reference #6619.The scrub technician has found holes in these before.The outer packaging was checked carefully, which was fine, but the inside packaging had a hole.The same thing occurred with the second one.We had to open three drapes to get one that was without blemish.Yesterday, there was also a problem with two drapes.

• Brand Name: STERI-DRAPE¿ IOBAN¿ 2
• Common Device Name: DRAPE, SURGICAL
• Manufacturer (Section D): 3M COMPANY; 3m center, 2510 conway ave.; bldg. 275-5w-06; st. paul MN 55144
• MDR Report Key: 7337577
• Report Number: 7337577
• Device Sequence Number: 11084612
• Product Code: KKX
• UDI-Device Identifier: 00707387444358
• UDI-Public: (01)00707387444358(17)191228(10)201912SB
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/01/2018
• Report Date (Section F): 03/01/2018

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: Other
• Device Expiration Date: 12/28/2019
• Device Model Number: 6619
• Device Catalogue Number: 6619
• Device Lot Number: 201912SB
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 03/01/2018
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/14/2018
• 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: 03/01/2018