MAUDE Adverse Event Report: SVS LLC PREMIERPRO; DRAPE, SURGICAL

Model Number 8326B

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/02/2019

Event Type  malfunction  

Event Description

A hair was found in a pack of blue disposable towels prior to the patient entering the or.Sterile field removed and reset.Packaging saved.Hair and towels not saved.

• Brand Name: PREMIERPRO
• Type of Device: DRAPE, SURGICAL
• Manufacturer (Section D): SVS LLC; 14120 ballantyne corporate pl ste 425; charlotte NC 28277
• MDR Report Key: 9202247
• MDR Text Key: 162641391
• Report Number: 9202247
• Device Sequence Number: 1
• Product Code: KKX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 8326B
• Device Lot Number: CBI05-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/03/2019
• Event Location: Hospital
• Date Report to Manufacturer: 10/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1