MAUDE Adverse Event Report: CARDINAL HEALTH JP 3-SPRING RES W/10FR PVC DRAIN/TR; APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED

Model Number	SU130-402D
Medical Device Problem Code	Microbial Contamination of Device (2303)
Health Effect - Clinical Code	Post Operative Wound Infection (2446)
Date of Event	02/08/2024
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
"patient reported he recently had hip replacement surgery in which the jackson pratt drain tube was used and has since been recalled for sterility issues.Patient reports because of this he had to have emergency surgery due to the infection from drain tube.".

• Brand Name: JP 3-SPRING RES W/10FR PVC DRAIN/TR
• Common Device Name: APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED
• 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: 19289358
• Report Number: 1423537-2024-00016
• Device Sequence Number: 7130535
• Product Code: GCY
• UDI-Device Identifier: 10885380113147
• UDI-Public: 10885380113147
• 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
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 05/10/2024

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: SU130-402D
• Device Catalogue Number: SU130-402D
• Device Lot Number: 231151D2
• 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: 04/17/2024
• Initial Report FDA Received Date: 05/10/2024
• 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; Hospitalization
• Patient Age: 51 YR
• Patient Sex: Male
• Patient Weight: 87 KG