MAUDE Adverse Event Report: CARDINAL HEALTH SCD EXPRESS TUBING SET; SLEEVE, LIMB, COMPRESSIBLE

Model Number	9528
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Event or Problem Description
The customer reported last year, they had a visitor who sustained a fall with significant injuries after tripping over the clear scd tubing that extends between the machine and the patient.As part of the process improvement plan, they identified the length of the scd tubing (approximately 5 feet) to be a risk factor for additional occurrences.The patients only wear the scds while in bed and are off when the patient is sitting in a chair or while ambulating.When the tubing is disconnected, it often slides off of the bed and onto the floor.They have evaluated ways to secure the tubing and cords but have not been successful due to infection control/prevention methods.They have also educated the staff to be extra mindful of all cords and tubing.Sometimes it is not staff who disconnect the devices, but the patient or family members.The customer is asking if it is possible to reduce the length of the scd tubing.Additional information received stated the visitor that fell sustained a comminuted left superior pubic ramus fracture and non-displaced fracture of the left ishium.He was admitted but didn't have any surgery.
Additional Manufacturer Narrative
H4 device manufacture date was added.The device history record (dhr) was reviewed showing no discrepancy.The physical sample was not returned; however, three images were provided for reference.It was not possible to confirm the reported condition through the images.The reported condition was not confirmed.A walk through was performed in the manufacturing process showing current process and controls were followed correctly.An exact root cause could not be determined nor found to be related to the manufacturing process.No action plan is deemed required.It is important to note that the incident was related to a visitor in the environment that the device was being used in and there were no complaints associated with the patient/user of the device.This complaint will be used for tracking and trending purposes.

• Brand Name: SCD EXPRESS TUBING SET
• Common Device Name: SLEEVE, LIMB, COMPRESSIBLE
• Manufacturer (Section D): CARDINAL HEALTH; 777 west street; mansfield MA 02048
• Manufacturer (Section G): CARDINAL HEALTH; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• Manufacturer Contact: jill saraiva ; 777 west street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 19078878
• Report Number: 9612030-2024-00056
• Device Sequence Number: 6677554
• Product Code: JOW
• UDI-Device Identifier: 10192253016284
• UDI-Public: 10192253016284
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• 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 Model Number: 9528
• Device Catalogue Number: 9528
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/02/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/10/2024
• Supplement Report FDA Received Date: 07/02/2024
• Date Device Manufactured: 05/18/2023
• Usage of Device: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male