MAUDE Adverse Event Report: MEDLINE INDUSTRIES; BLADE IN SINGLE BASIN PACK

Catalog Number DYNJ38164A

Device Problem Degraded (1153)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/16/2017

Event Type  malfunction  

Manufacturer Narrative

It was reported that a surgeon noticed rust on scalpel blade after being used.The rust was not noticed on the blade before use and blades were not visually inspected prior to use.The blades were used to make the initial incision and used within the surgical site.No harm came to the patient.Sample was received and issue was confirmed.Due to the reported incident and in an abundance of caution this medwatch is being filed.

Event Description

It was reported a blade had rust on it.

• Type of Device: BLADE IN SINGLE BASIN PACK
• Manufacturer (Section D): MEDLINE INDUSTRIES; three lakes drive; northfield IL 60093
• Manufacturer Contact: megan debus ; three lakes drive; northfield, IL 60093 ; 8477703962
• MDR Report Key: 6373104
• MDR Text Key: 69165145
• Report Number: 1423395-2017-00006
• 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: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: DYNJ38164A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 02/16/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 74 YR