MAUDE Adverse Event Report: CARDINAL HEALTH 200, LLC JACKSON-PRATT; CATHETER, IRRIGATION

Model Number	JP-2211
Health Effect - Clinical Code	Pain (1994)
Date of Event	05/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
1315 paged pa [physician assistant], to inform upon removal of jp [jackson-pratt] drain some resistance notice.Drain seems embedded inside the skin.Rn, at bedside asses, try to retrieve the drain and unable to do so.Stop any additional attempt.Place a new dressing.Pt aware of situation, no distress noted.Inform charge nurse, and primary rn of current situation.1325 paged dr.Regarding not being able to remove jp drain.Aware no, new orders at this time 1345 paged again, pa for new orders.Awaiting response.1400 paged alternate pa, inform him regarding the jp drain situation.Per pa, will come to assess at bedside.1417 pa at bedside.1445 bedside sterile procedure, performed by pa.Successfully remove jp drain, no retrain object.Pt tolerated well.Asses and change surgical site.Pt stated pain 10/10, dilaudid given per order.1500 per pa, is okay to continue with discharge.

• Brand Name: JACKSON-PRATT
• Common Device Name: CATHETER, IRRIGATION
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC; 3651 birchwood drive; waukegan IL 60085
• MDR Report Key: 22166194
• Report Number: 22166194
• Device Sequence Number: 20780711
• Product Code: GBX
• UDI-Device Identifier: 00885380020493
• UDI-Public: (01)00885380020493
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 06/03/2025
• Report Date (Section F): 06/03/2025

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: Other
• Device Model Number: JP-2211
• Device Catalogue Number: JP-2211
• Device Lot Number: P2309668
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 06/09/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/09/2025
• 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
• Patient Age: 70 YR
• Patient Sex: Male
• Date Report Sent to FDA: 06/03/2025