MAUDE Adverse Event Report: CARDINAL HEALTH JP 3-SPRING RES W/7FR PVC DRAIN/TR; CATHETER, IRRIGATION

Model Number	SU130-401D
Medical Device Problem Code	Microbial Contamination of Device (2303)
Health Effect - Clinical Code	Post Operative Wound Infection (2446)
Date of Event	01/17/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Mw5154605: customer reported a patient had a right anterior total hip arthroplasty on (b)(6) 2024, in which a jackson-pratt 3-spring reservoir kit with pvc round drain, 7fr distributed by cardinal health was placed.On 3/28/24 we were notified by cardinal health of a product recall due to product not being sterilized prior to distribution.This patient obtained a post operative infection diagnosed and was started on oral antibiotics.Patient received multiple debridement¿s in office and eventually required negative pressure wound therapy.This patient is believed to have received a non-sterile drain resulting in surgical complications.A wound culture obtained from a surgical wound should have no growth.
Additional Manufacturer Narrative
Cardinal health has issued a lot number specific voluntary removal of jackson-pratt¿ 3-spring reservoir kits due to specific products being shipped to users before undergoing sterilization.The fda res number associated with this action is 94309.Corrective and preventative actions have been initiated to address this event under capa number qe-000369.

• Brand Name: JP 3-SPRING RES W/7FR PVC DRAIN/TR
• Common Device Name: CATHETER, IRRIGATION
• Manufacturer (Section D): CARDINAL HEALTH; 3651 birchwood drive; waukegan IL 60085
• Manufacturer (Section G): CARDINAL HEALTH; 3651 birchwood drive; waukegan IL 60085
• Manufacturer Contact: patricia tucker ; 3651 birchwood drive; waukegan, IL 60085 ; 8478874151
• MDR Report Key: 19525206
• Report Number: 1423537-2024-00034
• Device Sequence Number: 12652345
• Product Code: GBX
• UDI-Device Identifier: 10192253016413
• UDI-Public: 10192253016413
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 06/12/2024

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
• Operator of Device: Health Professional
• Device Model Number: SU130-401D
• Device Catalogue Number: SU130-401D
• Device Lot Number: 231251D1
• 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: 05/23/2024
• Initial Report FDA Received Date: 06/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female
• Patient Weight: 91 KG