MAUDE Adverse Event Report: PRODUCTOS MEDLINE S.A. DE C.V.; SINGLE LUMEN TUBING CHANGE KIT

Catalog Number	LC385
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	06/05/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the customer on (b)(6), "the nurse changed the infant's central line iv fluids.The nurse primed all lines attached to the equipment given and all lines flushed easily.Iv fluids were clear fluids.The nurse completed all sterile procedure steps to complete umbilical vein central line.The nurse connected primed iv tubing to uvc and started charting.After 5 minutes, the infusion pump alarmed that there was air in the line.The nurse proceeded to trace lines to find the source of the air, but no air bubbles were in the line.The nurse noticed the bed was leaking with blood at the end of the iv tubing.".
Additional Manufacturer Narrative
According to the customer on 6/5, "the nurse changed the infant's central line iv fluids.The nurse primed all lines attached to the equipment given and all lines flushed easily.Iv fluids were clear fluids.The nurse completed all sterile procedure steps to complete umbilical vein central line.The nurse connected primed iv tubing to uvc and started charting.After 5 minutes, the infusion pump alarmed that there was air in the line.The nurse proceeded to trace lines to find the source of the air, but no air bubbles were in the line.The nurse noticed the bed was leaking with blood at the end of the iv tubing.There was a hole in the tubing dripping with blood.The infant lost some blood and bedding had to be changed.New fluids were put up until the pharmacy could remake the fluids wasted.All infant's vital signs are wdl at this time and oxygen requirement is still low.Orders were given and completed.The nurse primed the tubing and hung the iv fluid as normal.While she was cleaning her area, she noted blood and iv fluids on the bed.There was no serious injury".The device is available for evaluation.It has been determined that the reported event could cause or contribute to serious injury if it were to occur.In an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

• Common Device Name: SINGLE LUMEN TUBING CHANGE KIT
• Manufacturer (Section D): PRODUCTOS MEDLINE S.A. DE C.V.; blvd world trade center no.10; parque industrial oradel; nuevo laredo tamaulipas, 88285 ; MX 88285
• Manufacturer Contact: alex mathew ; three lakes drive; northfield, IL 60093-2753 ; 2249317042
• MDR Report Key: 19656021
• Report Number: 3004122598-2024-00039
• Device Sequence Number: 6549750
• Product Code: LRO
• UDI-Device Identifier: 40193489466578
• UDI-Public: 40193489466578
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Catalogue Number: LC385
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/06/2024
• Initial Report FDA Received Date: 07/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female
• Patient Weight: 2 KG