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

Model Number SU130-0321

Device Problem Fracture (1260)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/09/2022

Event Type  Injury  

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 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
• Type of Device: 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
• MDR Text Key: 294856688
• Report Number: 1423537-2022-00784
• Device Sequence Number: 1
• Product Code: GCY
• UDI-Device Identifier: 10192253022230
• UDI-Public: 10192253022230
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Date Manufacturer Received: 05/17/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 59 YR
• Patient Sex: Male
• Patient Weight: 88 KG