MAUDE Adverse Event Report: SAFETY NEO-SERT UVC TRAY W/O C; UMBILICAL CATHETER INSERTION TRAY

Model Number	43201
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/19/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The incident sample has been requested but to date has not been received for evaluation.  if the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted.  as part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.
Event or Problem Description
Customer reports: the #11 safety scalpel in the kit will not disengage the safety device for the scalpel to be used.Another tray was used and the safety device disengaged normally.
Additional Manufacturer Narrative
Section d2 product code updated from fos catheter, umbilical artery to pxj umbilical catheter insertion tray. .
Additional Manufacturer Narrative
The product reported is a uvc insertion tray which provides the components needed for conducting a catheter insertion procedure.One of the components included in this kit is a safety scalpel which is provided by an external supplier.The scalpel has 3 different positions: open, close and locked.Once locked, and for safety reasons as the name indicates, it cannot be re-opened.This locking feature was implemented to meet occupational safety and health administration (osha) requirements to prevent sharps injuries.To initially open the scalpel, force needs to be applied towards the open sign.If the security lid is moved towards the blade (upwards), the lid will lock, and the scalpel cannot be used.The device history record (dhr) was reviewed and indicated that the product was released accomplishing all quality standards.All quality assurance testing performed during manufacturing was acceptable.The quality assurance review of the visual, physical, and dimensional evaluation results indicated that the product met specification requirements.In addition, all dhr are reviewed for accuracy prior to product release.The actual sample involved in the reported incident was not returned for evaluation.No additional information, pictures, or videos were received.Consequently, it was not possible to evaluate the device as part of a comprehensive failure investigation and the exact root cause could not be determined.Preliminary evaluation shows that the reported issue is potentially related to inadvertently locking the scalpel during improper handling of the product.Additionally, it was found that the reported uvc kit does not include instructions for use (ifu) for the scalpel.Based on a medical safety assessment, not including the ifu information for the safety scalpel prevents clinicians from being made aware of the permanent locking feature of this safety scalpel which can create a delay to treatment/therapy and may contribute to patient/user harm.As part of continuous improvements, a corrective and preventative action (capa) has been opened.An ifu for the safety scalpel will be created and incorporated into the uvc kit tray part number 43201.The capa will also determine if any additional actions are needed to prevent the reoccurrence of the reported condition.

• Brand Name: SAFETY NEO-SERT UVC TRAY W/O C
• Common Device Name: UMBILICAL CATHETER INSERTION TRAY
• MDR Report Key: 11897645
• Report Number: 3009211636-2021-00749
• Device Sequence Number: 1390121
• Product Code: PXJ
• UDI-Device Identifier: 10884527005079
• UDI-Public: 10884527005079
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/09/2021
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: 43201
• Device Catalogue Number: 43201
• Device Lot Number: 2102100068
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/26/2021
• Supplement Date Received by Manufacturer: 05/26/2021; 05/26/2021
• Initial Report FDA Received Date: 05/27/2021
• Supplement Report FDA Received Date: 07/27/2021; 08/09/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/24/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: N
• Patient Sequence Number: 1