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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.
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Type of DeviceSCALPEL
Manufacturer (Section D)
50 alliance blvd
barrie, ontario L4M 5 K3
CA L4M 5K3
Manufacturer (Section G)
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 Key11808927
MDR Text Key252871362
Report Number8022003-2021-00001
Device Sequence Number1
Product Code GES
Combination Product (y/n)N
Reporter Country CodeCS
Number of Events Reported1
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 Received05/11/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number73-1811
Device Catalogue Number73-1811
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/15/2021
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 Treatment Data
Date Received: 05/11/2021 Patient Sequence Number: 1