MAUDE Adverse Event Report: CARDINAL HEALTH 200, LLC 10FR SILICONE DRAIN WITH TROCAR; APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED

Model Number	SU130-0321
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/09/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A product sample was not available for evaluation and the lot number was not provided for the drain.Without a lot number we are unable to trace the device history record for quality testing performed and corresponding results.The non-conformance report data since may 2021 to present was reviewed and no issues that could be related to the catalog and condition reported were found.A root cause for the reported concern cannot be identified with the amount of information available.As a preventive action, the customer will be provided with a copy of the instructions for use.It is recommended to strictly follow the instructions provided in the instruction for use data included with the product to ensure drains are properly used.Cardinal health will continue to monitor trends and utilize the information as part of continuous improvement.
Event or Problem Description
A 10fr channel drain was placed in patient during surgery.Registered nurse met resistance when attempting to remove.Nurse notified the physician who guided her through the removal of the jp drain.The tip of the device was examined and appeared intact.During a follow up visit, a surgeon noted retained foreign object that was a piece of broken jp drain.Patient returned to surgery and retained drain tubing was successfully removed.According to the medical record, a scalpel was used to make a small incision to remove the drain from the patient.The broken section was removed while the patient was under general anesthesia.The patient required stitches.Patient was discharged home the same day.We have received no additional information on how patient is doing now.

• Brand Name: 10FR SILICONE DRAIN WITH TROCAR
• Common Device Name: APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC; 3651 birchwood dr.; waukegan IL 60085
• Manufacturer (Section G): PR006 PUERTO RICO-ANASCO; state rd. 402 , north km 0.9; anasco PR 00610
• Manufacturer Contact: patricia tucker ; 3651 birchwood dr.; waukegan, IL 60085 ; 8478874151
• MDR Report Key: 14658546
• Report Number: 1423537-2022-00784
• Device Sequence Number: 4004879
• Product Code: GCY
• UDI-Device Identifier: 10192253022230
• UDI-Public: 10192253022230
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 06/10/2022

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: SU130-0321
• Device Catalogue Number: SU130-0321
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/17/2022
• Initial Report FDA Received Date: 06/10/2022
• 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: Other
• Patient Age: 59 YR
• Patient Sex: Male
• Patient Weight: 88 KG