MAUDE Adverse Event Report: FIRSTAR HEALTHCARE COMPANY LIMITED CARDINAL HEALTH; APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED

Model Number	SU130-404D
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	Muscle Weakness/Atrophy (1967)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An investigation is currently in progress.A follow-up report will be filed once the results have been completed.
Event or Problem Description
Customer reported that their unit has been having issues with the cardinal health¿ jackson-pratt® pvc round drain 3-spring reservoir kit with trocar, 400ml, 19fr for over a year.They are just now reporting it because they didn't know who to report to.The drain is clogging in the tubing every 12 hours post-operatively.They are having to manually unclog them.They have had patients start bleeding but no further information was provided to cardinal, and one patient had a drop foot due to the drain and had to go back into surgery.The issue was reported to the or manager at the time.They did not keep the drain(s) that were causing the issue and do not have samples or lot numbers.They changed to a new type of drain - the bulb jp drain from cardinal.Exact event date is unknown.
Additional Manufacturer Narrative
The device history record (dhr) could not be reviewed as no lot information was provided within the complaint.Prior to a lot's release, the lot must be deemed acceptable by-passing inspections that are based on a valid sampling plan.During production, inspectors routinely examine a statistical sample both physically and visually.There were no samples returned for evaluation; therefore, the affected device could not be evaluated to confirm the reported failure.As such, a root cause could not be determined.Instructions for use state that the drain must not be allowed to become occluded nor the reservoir to completely fill, as all wound drainage ceases.If occlusion does occur, the drain can be aspirated by connecting suction to port b or by applying suction directly to the drain.If the reservoir is not emptied when it is full, the likelihood of back-contamination increases.No similar complaint has been received regarding this reported incident.We will continue to monitor related reports to determine if additional actions are necessary.

• Brand Name: CARDINAL HEALTH
• Common Device Name: APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED
• Manufacturer (Section D): FIRSTAR HEALTHCARE COMPANY LIMITED; 555 north panyu avenue; guangzhou 51149 3; CH 511493
• Manufacturer (Section G): FIRSTAR HEALTHCARE COMPANY LIMITED; 555 north panyu avenue; guangzhou 51149 3; CH 511493
• Manufacturer Contact: jill saraiva ; 3651 birchwood drive; waukegan, IL 60085 ; 5086183640
• MDR Report Key: 21946499
• Report Number: 1423537-2025-00188
• Device Sequence Number: 12962337
• Product Code: GCY
• UDI-Device Identifier: 10192253016444
• UDI-Public: (01)10192253016444
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/13/2025

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: SU130-404D
• Device Catalogue Number: SU130-404D
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 04/16/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/16/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/01/2025
• Supplement Report FDA Received Date: 05/13/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown