MAUDE Adverse Event Report: SWANN-MORTON LTD SWANN MORTON; SCALPEL BLADE

Model Number 0201

Device Problems Break (1069); Device Contamination with Body Fluid (2317)

Patient Problem No Information (3190)

Event Date 10/08/2018

Event Type  malfunction  

Event Description

When we received the complaint initially of (b)(6) it was stated as "broken blade in pack".Due to the nature of this complaint it was not deemed to be an adverse reportable incident.Following communication with the healthcare facility on (b)(6) it was stated that they believed that the blade had actually broken in a procedure as they received a sample and it appeared to be contaminated with blood.We are aware that the incident has not been reported within the specified timescale; however, on initial notification of this complaint it was stated that the blade had broken in the pack.

• Brand Name: SWANN MORTON
• Type of Device: SCALPEL BLADE
• Manufacturer (Section D): SWANN-MORTON LTD; penn works owlerton green; sheffield, ; UK
• Manufacturer (Section G): SWANN-MORTON LTD; penn works owlerton green; sheffield, ; UK
• Manufacturer Contact: kevin walls ; 33 golden eagle lane; littleton, CO 80127 ; 7209625412
• MDR Report Key: 8217457
• MDR Text Key: 132213706
• Report Number: 9611194-2019-00001
• Device Sequence Number: 1
• Product Code: GES
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 01/04/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2022
• Device Model Number: 0201
• Device Lot Number: 4821710
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/10/2019
• Initial Date FDA Received: 01/04/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/12/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other