MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. MEDLINE GENERAL SURGERY TRAY (KIT); BLADE, SCALPEL

Lot Number 103547

Device Problem Material Integrity Problem (2978)

Patient Problem No Information (3190)

Event Date 12/22/2016

Event Type  malfunction  

Event Description

Noted by scrub tech when setting up for case the tip of the number 10 knife blade (mfg bard parker, lot#0103547) had a score in it.The blade was included in the medline general pack ((b)(4), lot #16jb3994.Blade removed from the field.

• Brand Name: MEDLINE GENERAL SURGERY TRAY (KIT)
• Type of Device: BLADE, SCALPEL
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; one medline pl.; mundelein IL 60060
• MDR Report Key: 6289258
• MDR Text Key: 66145813
• Report Number: 6289258
• Device Sequence Number: 1
• Product Code: LRO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: 103547
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/18/2017
• Event Location: Other
• Date Report to Manufacturer: 01/18/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 63 YR