MAUDE Adverse Event Report: HILL-ROM, INC. ASPEN BLADE PROTECTED SIZE 15; BLADE, SCALPEL

Model Number 0507373915

Device Problem Device Contaminated During Manufacture or Shipping (2969)

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

Event Date 12/10/2018

Event Type  malfunction  

Event Description

Safety blade is packages in a sterile pack.It was noted before the blade was removed from the packaging that there was a clear, substance inside the sterile package.It was removed as soon as the scrub person noted it.So far, 7 other blades with the same lot number have been removed from the packs.

• Brand Name: ASPEN BLADE PROTECTED SIZE 15
• Type of Device: BLADE, SCALPEL
• Manufacturer (Section D): HILL-ROM, INC.; 1069 state route 46 east; batesville IN 47006
• MDR Report Key: 8184008
• MDR Text Key: 131004502
• Report Number: 8184008
• Device Sequence Number: 1
• Product Code: GES
• 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: 12/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2018
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 0507373915
• Device Catalogue Number: 373915
• Device Lot Number: 0167188
• 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: 12/11/2018
• Event Location: Hospital
• Date Report to Manufacturer: 12/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1