MAUDE Adverse Event Report: CARDINAL HEALTH 200, LLC CARDINAL HEALTH; APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED

Model Number	SU130-1305
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/24/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Jackson pratt drain bulb not staying compressed as designed.The nurse compressed the bulb and it lost suction and stopped working after about five minutes.The nurse decided to switch the bulb and when they began that process, the bulb's connection to the tubing was very loose.The nurse replaced the defective bulb with a new bulb and the drain functioned as designed.

• Brand Name: CARDINAL HEALTH
• Common Device Name: APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC; 3651 birchwood drive; waukegan IL 60085
• MDR Report Key: 24910243
• Report Number: 24910243
• Device Sequence Number: 9874222
• Product Code: GCY
• UDI-Device Identifier: 10192253022339
• UDI-Public: (01)10192253022339(17)300731(10)1250597
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 04/03/2026
• Report Date (Section F): 04/03/2026

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
• Device Model Number: SU130-1305
• Device Catalogue Number: SU130-1305
• Device Lot Number: 1250597
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 04/17/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/17/2026
• 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 Age: 70 YR
• Patient Sex: Female
• Patient Weight: 72 KG
• Date Report Sent to FDA: 04/03/2026