MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP. UMBILICAL CORD KIT; TRAY, SURGICAL

Model Number	DYNDA2665
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/12/2022
Type of Reportable Event	Malfunction
Event or Problem Description
While placing umbilical lines on a premature infant with the standard umbilical line kit kept in the nicu.Md cut the cord down with the light blu scalpel and when md pressed the button to retract the needle back into the device, the scapel shot back at md (not the sharp part) and fell to the ground.Md was not struck by the scapel and no one was harmed, but the scapel certainly seems like it was broken in some way.Scalpel was disposed.There was no patient involved in this event.There was no harm to provider or patient.

• Brand Name: UMBILICAL CORD KIT
• Common Device Name: TRAY, SURGICAL
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP.; three lakes drive; northfield IL 60093
• MDR Report Key: 15064635
• Report Number: 15064635
• Device Sequence Number: 12193197
• Product Code: LRP
• UDI-Device Identifier: 10193489191899
• UDI-Public: (01)10193489191899(10)2022040490(17)230131
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/15/2022
• Report Date (Section F): 07/15/2022

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
• Operator of Device: Health Professional
• Device Model Number: DYNDA2665
• Device Catalogue Number: DYNDA2665
• Device Lot Number: 202204090
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 07/20/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/20/2022
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 07/15/2022