MAUDE Adverse Event Report: ROCKET MEDICAL PLC ROCKET IPC INSERTION SET; APPARATUS, SUCTION, PATIENT CARE

Model Number	R51400-16-00
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/23/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Adult male with history of diabetes mellitus (dm), metastatic pancreatic ca and resent shortness of breath.Procedure: placement of left pleural drainage catheter with ultrasound guidance.During the procedure, the tunneler broke when trying to tunnel through the pleural space.No known harm to patient.Manufacturer response for rocket ipc insertion set, rocket (per site reporter).Will obtain.

• Brand Name: ROCKET IPC INSERTION SET
• Common Device Name: APPARATUS, SUCTION, PATIENT CARE
• Manufacturer (Section D): ROCKET MEDICAL PLC; unit 1, 150 recreation; park drive; hingham MA 02043
• MDR Report Key: 13666270
• Report Number: 13666270
• Device Sequence Number: 14641505
• Product Code: DWM
• UDI-Device Identifier: 05055270965783
• UDI-Public: (01)05055270965783(17)230403(10)489422
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 02/23/2022
• Report Date (Section F): 02/23/2022

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: Health Professional
• Device Model Number: R51400-16-00
• Device Catalogue Number: R51400-16-00
• Device Lot Number: 489422
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Other
• Date Report to Manufacturer: 03/04/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/04/2022
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Weight: 67 KG
• Date Report Sent to FDA: 02/23/2022