MAUDE Adverse Event Report: SOUTHMEDIC INC. SOUTHMEDIC NON-STERILE DISPOSABLE SAFETY SCALPEL

Model Number 73-1811

Device Problem Device Handling Problem (3265)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

The manufacturer received notification of this incident on april 15, 2021.Per the customer, the safety scalpel, as part of an umbilical vessel catheter (uvc) tray, would not open as it was in the locked position, which delayed uvc placement.The customer could not confirm if the scalpel was received in the locked position or if locking occurred in the emergency room.This incident was also reported by the uvc kit manufacturer (3009211636-2020-00726).The safety scalpel associated with the incident is sold in bulk to the kit manufacturer for further packaging into procedure kits.Quality control checks are utilized by the safety scalpel manufacturer to ensure scalpels are not provided in a locked position.The incident was likely due to user error due to misunderstanding of how the safety scalpel opens, closes and locks.Alternative scalpel brands may have sheaths that are fully removed to expose the blade.The manufacturer safety scalpels retract to expose the blade, may be closed for safe passing and can be locked for safe disposal.

Event Description

The customer reported that in an emergency situation the scalpel in the uvc set appeared locked and was unable to be opened by the provider during a neonatal code situation.Additional information provided by the customer stated that there was a delay in treatment but was unsure how long the delay was.The customer stated it was a critical situation in the delivery room and that the newborn needed advanced resuscitation quickly.The uvc line needed to be placed but the scalpel could not be opened.Additional information provided by the customer stated that they could not pull the scalpel safety sheath down, stating that it was locked in.The customer stated that since the incident occurred in an emergency situation, they do not know if the scalpel was already in the locked position when removed from the uvc kit.They stated that they were finally able to open the scalpel and place the line into the patient.The newborn expired.The customer would not answer if they believed that the issue with the device caused or contributed to the patient's death.

• Brand Name: SOUTHMEDIC NON-STERILE DISPOSABLE SAFETY SCALPEL
• Type of Device: SCALPEL
• Manufacturer (Section D): SOUTHMEDIC INC.; 50 alliance blvd; barrie, ontario L4M 5 K3; CA L4M 5K3
• Manufacturer (Section G): SOUTHMEDIC INC.; 50 alliance blvd.; barrie, ontario L4M 5 K3; CA L4M 5K3
• Manufacturer Contact: tish whitehead ; 50 alliance blvd.; barrie, ontario L4M 5-K3 ; CA L4M 5K3
• MDR Report Key: 11808927
• MDR Text Key: 252871362
• Report Number: 8022003-2021-00001
• Device Sequence Number: 1
• Product Code: GES
• Combination Product (y/n): N
• Reporter Country Code: CS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 73-1811
• Device Catalogue Number: 73-1811
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/15/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other